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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04225897
Registration number
NCT04225897
Ethics application status
Date submitted
11/12/2019
Date registered
13/01/2020
Date last updated
23/10/2024
Titles & IDs
Public title
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
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Scientific title
A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)
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Secondary ID [1]
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C5241003
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Secondary ID [2]
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REVC003
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Universal Trial Number (UTN)
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Trial acronym
REVIRAL 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV)
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Lower Resp Tract Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RV521
Treatment: Drugs - Placebo
Experimental: RV521 - sisunatovir is formulated as a dry powder blend of RV521 drug substance with mannitol as excipient. The RV521 dry powder blend will be supplied in capsules containing 10, 20, or 50 mg RV521. The Investigational Medicinal Product (IMP) will be dispersed in a defined volume of suspending diluent prior to oral administration on a mg/kg basis. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.
The proposed dosing regimen for Part A is a single open label dose of RV521. Part B and C is RV521 or placebo administered BID, 12 hours apart, for a period of 5 consecutive days with a total of 10 doses. However, this is subject to the recommendation of the DSMC.
Placebo comparator: Placebo - The placebo capsules administered in Part B and C will contain mannitol and microcrystalline cellulose (vehicle). The placebo dry powder will be dispersed in suspending diluent and given orally BID. Instructions for opening the capsule(s) and dispersing the contents in a fixed volume of suspending diluent prior to administration will be provided in the Pharmacy Manual.
Treatment: Drugs: RV521
RV521 is an RSV F protein inhibitor administered orally
Treatment: Drugs: Placebo
vehicle administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
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Assessment method [1]
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An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.
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Timepoint [1]
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From start of IMP on Day 1 up to Day 7
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Primary outcome [2]
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Part B: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Permanent Discontinuation of IMP
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Assessment method [2]
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An AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which did not necessarily have a causal relationship with the IMP. TEAEs were defined as AEs which started, or worsened, after the first dose of IMP. An SAE was any untoward medical occurrence or effect that, at any dose, resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity or other important medical event.
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Timepoint [2]
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From start of IMP on Day 1 up to Day 12
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Primary outcome [3]
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Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
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Assessment method [3]
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Physical examination included general appearance; head, eyes, ears, nose and throat (HEENT); dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
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Timepoint [3]
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Baseline (pre-dose on Day 1)
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Primary outcome [4]
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Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 18 to 24 Hours Post-dose
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Assessment method [4]
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Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
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Timepoint [4]
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Anytime between 18 to 24 hours post-dose on Day 1
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Primary outcome [5]
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Part A: Number of Participants With Abnormal Clinically Significant Physical Examination Results at 48 Hours Post-dose
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Assessment method [5]
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Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
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Timepoint [5]
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At 48 hours post-dose on Day 1
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Primary outcome [6]
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Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results at Baseline
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Assessment method [6]
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Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
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Timepoint [6]
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Baseline (pre-dose on Day 1)
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Primary outcome [7]
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Part B: Number of Participants With Abnormal Clinically Significant Physical Examination Results Anytime Between 40 to 48 Hours Post-dose 10
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Assessment method [7]
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Physical examination included general appearance, HEENT, dermatologic, cardiovascular, respiratory, gastrointestinal and neurological examination. Clinical significance of results were determined by the investigator.
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Timepoint [7]
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Anytime between 40 to 48 hours post-dose 10 on Day 5
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Primary outcome [8]
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Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Baseline
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Assessment method [8]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [8]
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Baseline (pre-dose on Day 1)
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Primary outcome [9]
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Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
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Assessment method [9]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [9]
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Anytime between 4 to 5 hours post-dose on Day 1
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Primary outcome [10]
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Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 12 Hours Post-Dose
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Assessment method [10]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [10]
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At 12 hours post-dose on Day 1
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Primary outcome [11]
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Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-Dose
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Assessment method [11]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [11]
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Anytime between 18 to 24 hours post-dose on Day 1
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Primary outcome [12]
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Part A: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at 48 Hours Post-Dose
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Assessment method [12]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [12]
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48 hours post-dose on Day 1
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Primary outcome [13]
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Part B: Number of Participants With Abnormal Vital Signs Per Investigator's Interpretation at Baseline
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Assessment method [13]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [13]
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Baseline (pre-dose on Day 1)
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Primary outcome [14]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
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Assessment method [14]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [14]
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Anytime between 4 to 5 hours post-dose 1 (Day 1)
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Primary outcome [15]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation At Pre-dose 2
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Assessment method [15]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 2= assessment prior to receiving dose 2 of IMP on Day 1.
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Timepoint [15]
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Pre-dose 2 (Day 1)
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Primary outcome [16]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 3
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Assessment method [16]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 3= assessment prior to receiving dose 3 of IMP on Day 2.
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Timepoint [16]
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Pre-dose 3 (Day 2)
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Primary outcome [17]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 4
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Assessment method [17]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 4= assessment prior to receiving dose 4 of IMP on Day 2.
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Timepoint [17]
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Pre-dose 4 (Day 2)
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Primary outcome [18]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 5
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Assessment method [18]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 5= assessment prior to receiving dose 5 of IMP on Day 3.
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Timepoint [18]
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0
Pre-dose 5 (Day 3)
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Primary outcome [19]
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0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 6
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Assessment method [19]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 6= assessment prior to receiving dose 6 of IMP on Day 3.
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Timepoint [19]
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0
Pre-dose 6 (Day 3)
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Primary outcome [20]
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Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
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Assessment method [20]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [20]
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0
Anytime between 4 to 5 hours post-dose 6 (Day 3)
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Primary outcome [21]
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0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 7
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Assessment method [21]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 7= assessment prior to receiving dose 7 of IMP on Day 4.
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Timepoint [21]
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Pre-dose 7 (Day 4)
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Primary outcome [22]
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0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 8
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Assessment method [22]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 8= assessment prior to receiving dose 8 of IMP on Day 4.
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Timepoint [22]
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0
Pre-dose 8 (Day 4)
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Primary outcome [23]
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0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 9
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Assessment method [23]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 9= assessment prior to receiving dose 9 of IMP on Day 5.
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Timepoint [23]
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0
Pre-dose 9 (Day 5)
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Primary outcome [24]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation at Pre-dose 10
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Assessment method [24]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure. Predose 10= assessment prior to receiving dose 10 of IMP on Day 5.
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Timepoint [24]
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0
Pre-dose 10 (Day 5)
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Primary outcome [25]
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0
Part B: Number of Participants With Abnormal Clinically Significant Vital Signs Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
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Assessment method [25]
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Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate, heart rate and pulse oximetry. Number of participants with abnormal clinically significant vital signs per investigator's interpretation are reported in this outcome measure.
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Timepoint [25]
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0
Anytime between 40 to 48 hours post-dose 10 on Day 5
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Primary outcome [26]
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0
Part A: Number of Participants With Abnormal Hematology Results at Baseline
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Assessment method [26]
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Hematology parameters included basophils, eosinophils, mean cell hemoglobin concentration (MCHC), mean cell hemoglobin (MCH), mean cell volume (MCV), red blood cell count (RBC), hematocrit (HCT), hemoglobin (Hb), white blood cell count (WBC), lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
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Timepoint [26]
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Baseline (pre-dose on Day 1)
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Primary outcome [27]
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Part A: Number of Participants With Abnormal Hematology Results at 48 Hours Post-Dose
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Assessment method [27]
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Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
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Timepoint [27]
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0
At 48 hours post-dose on Day 1
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Primary outcome [28]
0
0
Part B: Number of Participants With Abnormal Hematology Results at Baseline
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Assessment method [28]
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Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
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Timepoint [28]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [29]
0
0
Part B: Number of Participants With Abnormal Hematology Results Anytime Between 40 to 48 Hours Post-dose 10
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Assessment method [29]
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Hematology parameters included basophils, eosinophils, MCHC, MCH, MCV, RBC, HCT, Hb, WBC, lymphocytes, monocytes, neutrophils and platelet count. Institutional laboratory normal ranges were used.
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Timepoint [29]
0
0
Anytime between 40 to 48 hours post-dose 10 on Day 5
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Primary outcome [30]
0
0
Part A: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
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Assessment method [30]
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Clinical chemistry parameters included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
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Timepoint [30]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [31]
0
0
Part A: Number of Participants With Abnormal Clinical Chemistry Results at 48 Hours Post-Dose
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Assessment method [31]
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Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
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Timepoint [31]
0
0
At 48 hours post-dose on Day 1
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Primary outcome [32]
0
0
Part B: Number of Participants With Abnormal Clinical Chemistry Results at Baseline
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Assessment method [32]
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Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
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Timepoint [32]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [33]
0
0
Part B: Number of Participants With Abnormal Clinical Chemistry Results Anytime Between 40 to 48 Hours Post-dose 10
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Assessment method [33]
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0
Clinical chemistry parameters included ALT, albumin, ALP, AST, bilirubin, calcium, chloride, creatinine, GGT, glucose, LDH, potassium, protein, sodium and urea. Institutional laboratory normal ranges were used.
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Timepoint [33]
0
0
Anytime between 40 to 48 hours post-dose 10 on Day 5
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Primary outcome [34]
0
0
Part A: Number of Participants With Abnormal Urinalysis Results at Baseline
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Assessment method [34]
0
0
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per high power field \[hpf\]), erythrocytes (0 to 2 per hpf), granular casts (0 per low power field \[lpf\]), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
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Timepoint [34]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [35]
0
0
Part A: Number of Participants With Abnormal Urinalysis Results at 48 Hours Post-dose
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Assessment method [35]
0
0
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and potential of hydrogen (pH) (5 to 8).
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Timepoint [35]
0
0
At 48 hours post-dose on Day 1
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Primary outcome [36]
0
0
Part B: Number of Participants With Abnormal Urinalysis Results at Baseline
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Assessment method [36]
0
0
Following urine parameters were analyzed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
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Timepoint [36]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [37]
0
0
Part B: Number of Participants With Abnormal Urinalysis Results Anytime Between 40 to 48 Hours Post-Dose 10
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Assessment method [37]
0
0
Following urine parameters were analysed: epithelial cells (normal range: 0 to 5 cells per hpf), erythrocytes (0 to 2 per hpf), granular casts (0 per lpf), hyaline casts (0 to 1 per lpf), leukocytes (0 to 5 per hpf), RBC casts (0 per lpf), WBC casts (0 per lpf), waxy casts (0 per lpf) and pH (5 to 8).
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Timepoint [37]
0
0
Anytime between 40 to 48 hours post-dose 10 on Day 5
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Primary outcome [38]
0
0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
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Assessment method [38]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QT interval corrected by Bazzett's formula (QTcB) interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [38]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [39]
0
0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose
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Assessment method [39]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [39]
0
0
Anytime between 4 to 5 hours post-dose on Day 1
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Primary outcome [40]
0
0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 18 to 24 Hours Post-dose
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Assessment method [40]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [40]
0
0
Anytime between 18 to 24 hours post-dose on Day 1
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Primary outcome [41]
0
0
Part A: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at 48 Hours Post-dose
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Assessment method [41]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [41]
0
0
48 hours post-dose on Day 1
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Primary outcome [42]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Baseline
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Assessment method [42]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [42]
0
0
Baseline (pre-dose on Day 1)
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Primary outcome [43]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 1
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Assessment method [43]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [43]
0
0
Anytime between 4 to 5 hours post-dose 1 on Day 1
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Primary outcome [44]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 3
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Assessment method [44]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
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Timepoint [44]
0
0
Pre-dose 3 (Day 2)
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Primary outcome [45]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 5
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Assessment method [45]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Query!
Timepoint [45]
0
0
Pre-dose 5 (Day 3)
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Primary outcome [46]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 4 to 5 Hours Post-Dose 6
Query!
Assessment method [46]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Query!
Timepoint [46]
0
0
Anytime between 4 to 5 hours post-dose 6 (Day 3)
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Primary outcome [47]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 8
Query!
Assessment method [47]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Query!
Timepoint [47]
0
0
Pre-dose 8 (Day 4)
Query!
Primary outcome [48]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation at Pre-dose 10
Query!
Assessment method [48]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Query!
Timepoint [48]
0
0
Pre-dose 10 (Day 5)
Query!
Primary outcome [49]
0
0
Part B: Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Results Per Investigator's Interpretation Anytime Between 40 to 48 Hours Post-Dose 10
Query!
Assessment method [49]
0
0
A 12-lead ECG was performed for assessment of following ECG parameters: ventricular heart rate, PR interval, QRS interval, QT interval and QTcB interval. Number of participants with abnormal clinically significant results for any ECG parameter per investigator's interpretation are reported in this outcome measure.
Query!
Timepoint [49]
0
0
Anytime between 40 to 48 hours post-dose 10 on Day 5
Query!
Secondary outcome [1]
0
0
Part A: Time to Maximum Plasma Concentration (Tmax)
Query!
Assessment method [1]
0
0
No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the Pharmacokinetic (PK) population.
Query!
Timepoint [1]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [2]
0
0
Part B: Time to Maximum Plasma Concentration (Tmax)
Query!
Assessment method [2]
0
0
No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [2]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [3]
0
0
Part A: Maximum Observed Plasma Concentration (Cmax)
Query!
Assessment method [3]
0
0
No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [3]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [4]
0
0
Part B: Maximum Observed Plasma Concentration (Cmax)
Query!
Assessment method [4]
0
0
No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [4]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [5]
0
0
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
Query!
Assessment method [5]
0
0
AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [5]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours post-dose on Day 1
Query!
Secondary outcome [6]
0
0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC0-12)
Query!
Assessment method [6]
0
0
AUC(0 to 12) was calculated using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [6]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [7]
0
0
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Query!
Assessment method [7]
0
0
Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [7]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [8]
0
0
Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC[0 to t])
Query!
Assessment method [8]
0
0
Area under the plasma concentration-time curve from time 0 to the last measurable concentration was determined using the linear trapezoidal method. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [8]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [9]
0
0
Part A: Terminal Half-life (t1/2)
Query!
Assessment method [9]
0
0
T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [9]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [10]
0
0
Part B: Terminal Half-life (t1/2)
Query!
Assessment method [10]
0
0
T1/2 was calculated as loge (2) divided by kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [10]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [11]
0
0
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
Query!
Assessment method [11]
0
0
AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [11]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [12]
0
0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0 to Inf)
Query!
Assessment method [12]
0
0
AUCinf was determined as AUC(0 to t) + (Clast/kel), where Clast was the plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis and kel was the terminal phase rate. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [12]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [13]
0
0
Part A: Trough Concentration at the End of First Dosing Interval (C12)
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
At 12 hours post-dose on Day 1
Query!
Secondary outcome [14]
0
0
Part B: Trough Concentration at the End of Dose 6 (C12)
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
At 12 hours post-dose 6
Query!
Secondary outcome [15]
0
0
Part A: Predicted Plasma Clearance
Query!
Assessment method [15]
0
0
Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [15]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [16]
0
0
Part B: Predicted Plasma Clearance
Query!
Assessment method [16]
0
0
Clearance was calculated as Dose divided by AUC(0 to inf). No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [16]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [17]
0
0
Part A: Apparent Volume of Distribution of the Drug After Extravascular Administration
Query!
Assessment method [17]
0
0
Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [17]
0
0
Anytime between 4 to 5 hours, anytime between 6 to 8 hours, 12 hours, 18 to 24 hours and 48 hours post-dose on Day 1
Query!
Secondary outcome [18]
0
0
Part B: Apparent Volume of Distribution of the Drug After Extravascular Administration
Query!
Assessment method [18]
0
0
Apparent volume of distribution was estimated as Dose/Kel\*AUC(0 to inf), where Kel=apparent first-order terminal elimination rate constant. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [18]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [19]
0
0
Part B: Accumulation Ratio
Query!
Assessment method [19]
0
0
Accumulation ratio was calculated as ratio of the area under the curve (AUC) during a single dosing interval under steady state conditions to the AUC during a dosing interval after one singe dose. No sampling was done at pre-dose (0 hour) on Day 1 and pre-dose results were imputed for all participants in the PK population.
Query!
Timepoint [19]
0
0
Day 1 Dose 1 (anytime between 4 to 5 hours post-dose, 12 hours post-dose), Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [20]
0
0
Part B: Percentage Fluctuation
Query!
Assessment method [20]
0
0
Percentage fluctuation was calculated as 100\*(Cmax-Cmin)/Cavg, where Cmin=minimum plasma concentration and Cmax measured over dosing interval.
Query!
Timepoint [20]
0
0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [21]
0
0
Part B: Area Under the Plasma Concentration Time Curve From Time Zero to the End of Last Dosing Interval (AUC0-tau)
Query!
Assessment method [21]
0
0
AUC(0 to tau) was determined using the linear trapezoidal method.
Query!
Timepoint [21]
0
0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [22]
0
0
Part B: Average Plasma Concentration Over Dosing Interval (Cavg)
Query!
Assessment method [22]
0
0
Cavg was estimated as AUC(0 to tau)/tau, where tau=dosing interval (12 hours).
Query!
Timepoint [22]
0
0
Day 3 Dose 6 (pre-dose, anytime between 4 to 5 hours post-dose, 12 hours post-dose)
Query!
Secondary outcome [23]
0
0
Part B: Minimum Observed Plasma Concentration
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Day 3 Dose 6 (pre-dose)
Query!
Secondary outcome [24]
0
0
Part B: Plasma Trough Concentration
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Day 3 Dose 6 (pre-dose)
Query!
Secondary outcome [25]
0
0
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)
Query!
Assessment method [25]
0
0
Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects analysis of covariance (ANCOVA) model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months.
Query!
Timepoint [25]
0
0
Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Query!
Secondary outcome [26]
0
0
Part B: Percent Change From Baseline in Logarithm to Base10 (Log10) Total RSV Viral Load by Cell-Based Infectivity Assay (CBIA)
Query!
Assessment method [26]
0
0
Percent change from baseline in log10 total RSV viral load was analyzed using a mixed effects ANCOVA model. The model was fitted to the participants treated at the final doses selected for Cohort 5 as pre-planned in statistical analysis plan for age group \>=1 month to \<6 months.
Query!
Timepoint [26]
0
0
Baseline (pre-dose on Day 1), 60 hours and 156 hours after first dose on Day 1
Query!
Secondary outcome [27]
0
0
Part B: Time to Resolution of RSV-Related Signs and Symptoms
Query!
Assessment method [27]
0
0
Time to resolution was calculated for RSV-related signs and symptoms that were present at study start and was defined as the time of randomization to the time that RSV-related signs and symptoms were absent.
Query!
Timepoint [27]
0
0
Up to Day 12
Query!
Secondary outcome [28]
0
0
Part B: Time to Improvement in RSV-Related Signs and Symptoms
Query!
Assessment method [28]
0
0
Time to improvement was calculated for RSV-related signs and symptoms that were classified as moderate or severe during the course of the study and was defined as the time from randomization to the time that RSV-related signs and symptoms were mild or absent.
Query!
Timepoint [28]
0
0
Up to Day 12
Query!
Secondary outcome [29]
0
0
Part B: RSV Clinical Scoring System Scores
Query!
Assessment method [29]
0
0
RSV clinical score was a composite score for infants with RSV infection \>= 1 month of age based on 4 items (respiratory rate, wheezing, retraction of respiratory muscles and general condition). Score for each item ranged from 0 to 3 where 0=none/normal and 3=severe. Total score was calculated as sum of individual items and ranged from 0 to 12, where higher score indicated severe disease. RSV symptoms were graded as mild: score \<=5, moderate: score \> 5 but \< 9 and severe: score \>=9.
Query!
Timepoint [29]
0
0
Baseline (pre-dose 1 on Day 1), pre-dose 3, pre-dose 5, pre-dose 7, pre-dose 9, anytime between 40 to 48 hours post-dose 10 on Day 5
Query!
Eligibility
Key inclusion criteria
1. Male or female = 1 month and = 36 months of age
2. Weight = 3.5 kg
3. Clinical diagnosis of LRTI
4. A positive RSV diagnostic test
5. Hospitalised because of RSV LRTI
6. Symptoms of LRTI must be present for no more than 1 week (Part B) and no more than 5 days (Part C) before the Screening Visit
7. Expected to remain in hospital for a minimum of 3 days
8. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate and are able and willing to comply with the study protocol
Query!
Minimum age
1
Month
Query!
Query!
Maximum age
36
Months
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Premature (gestational age less than 37 weeks) AND <1 year of post-natal age
2. Known to have significant comorbidities that would limit the ability to administer study drug or evaluate the safety or clinical response to study drug.
3. Any clinically significant ECG abnormalities.
4. Known to be immunocompromised.
5. High risk of having developing asthma.
6. Suspected of having a clinically significant bacterial infection.
7. History of renal failure.
8. Clinical evidence of hepatic decompensation
9. History of epilepsy or seizures, including febrile seizures
10. Allergy to test medication or constituents
11. Has received 1 or more doses of palivizumab at any time before Screening or received treatment with antiviral therapy for RSV (eg, ribavirin or intravenous [IV] immunoglobulin) within 3 months before the Screening Visit.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/11/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
51
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Caba
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Alberta
Query!
Country [4]
0
0
Chile
Query!
State/province [4]
0
0
Metropolitana
Query!
Country [5]
0
0
Chile
Query!
State/province [5]
0
0
Region DE LOS Lagos
Query!
Country [6]
0
0
Costa Rica
Query!
State/province [6]
0
0
San Jose
Query!
Country [7]
0
0
Hungary
Query!
State/province [7]
0
0
Budapest
Query!
Country [8]
0
0
Hungary
Query!
State/province [8]
0
0
Kaposvar
Query!
Country [9]
0
0
Israel
Query!
State/province [9]
0
0
Beer-Sheva
Query!
Country [10]
0
0
Israel
Query!
State/province [10]
0
0
Haifa
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Petach Tikava
Query!
Country [12]
0
0
Korea, Republic of
Query!
State/province [12]
0
0
Seoul
Query!
Country [13]
0
0
Malaysia
Query!
State/province [13]
0
0
Kelantan
Query!
Country [14]
0
0
Malaysia
Query!
State/province [14]
0
0
Perak
Query!
Country [15]
0
0
Malaysia
Query!
State/province [15]
0
0
Pulau Pinang
Query!
Country [16]
0
0
Malaysia
Query!
State/province [16]
0
0
Sarawak
Query!
Country [17]
0
0
Malaysia
Query!
State/province [17]
0
0
Terengganu
Query!
Country [18]
0
0
Malaysia
Query!
State/province [18]
0
0
Parek
Query!
Country [19]
0
0
New Zealand
Query!
State/province [19]
0
0
Wellington
Query!
Country [20]
0
0
Panama
Query!
State/province [20]
0
0
Panama
Query!
Country [21]
0
0
Poland
Query!
State/province [21]
0
0
Krakow
Query!
Country [22]
0
0
Poland
Query!
State/province [22]
0
0
Lodz
Query!
Country [23]
0
0
Poland
Query!
State/province [23]
0
0
Warszawa
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Barcelona
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Madrid
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
Pamplona
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Santiago de Compostela
Query!
Country [28]
0
0
Taiwan
Query!
State/province [28]
0
0
Hsinchu City
Query!
Country [29]
0
0
Taiwan
Query!
State/province [29]
0
0
Hualien
Query!
Country [30]
0
0
Taiwan
Query!
State/province [30]
0
0
Kaohsiung City
Query!
Country [31]
0
0
Taiwan
Query!
State/province [31]
0
0
Tainan City
Query!
Country [32]
0
0
Thailand
Query!
State/province [32]
0
0
Bangkok
Query!
Country [33]
0
0
Thailand
Query!
State/province [33]
0
0
Chiang Mai
Query!
Country [34]
0
0
Thailand
Query!
State/province [34]
0
0
Chiangrai
Query!
Country [35]
0
0
Thailand
Query!
State/province [35]
0
0
khon Kaen
Query!
Country [36]
0
0
Thailand
Query!
State/province [36]
0
0
Khon Kaen
Query!
Country [37]
0
0
Thailand
Query!
State/province [37]
0
0
Phitsanulok
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Liverpool
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
London
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections. This study will assess sisunatovir as compared to placebo in infants aged 1 month to 36 months who are hospitalized with RSV lower respiratory tract infection (LRTI). A placebo looks like the study medicine but does not contain any active medicine in it. This study will be conducted in 3 parts: In Part A participants aged 6 months to 3 years will be given a single dose of 2.5 mg/kg of sisunatovir in Cohort 1. In Cohort 2, participants age 1 month to 6 months will receive a single dose of 2 mg/kg of sisunatovir only after the completion of Cohort 1. 12-24 participants will be enrolled in Part A In Part B participants age 1 month to 36 months will receive sisunatovir or placebo dosed every 12 hours for 5 days. Doses for part B will be determined after the completion of Part A. 24-40 participants will be enrolled in Part B. The dose regimen for Part C will be determined after the completion of Part B. Approximately 120 participants age 1 month to 36 months will receive either sisunatovir or placebo. To participate in this study participants must meet the following criteria: 1. Age 1 month to 36 months 2. Weight = 3.5 kg 3. Diagnosis of LRTI 4. Diagnosis of RSV 5. Hospitalization due to RSV LRTI
Query!
Trial website
https://clinicaltrials.gov/study/NCT04225897
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/97/NCT04225897/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/97/NCT04225897/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04225897
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