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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06627556
Registration number
NCT06627556
Ethics application status
Date submitted
3/10/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Titles & IDs
Public title
A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
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Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of H021 in Healthy Participants
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Secondary ID [1]
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KFP-2024-H021-HW-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - H021
Treatment: Drugs - H021 Placebo
Experimental: SAD Cohort 1: H021 6.25 milligrams (mg) - Participants will receive H021, 6.25 mg oral tablet, as single-dose on Day 1 under fasting or fed conditions.
Experimental: SAD Cohort 2: H021 12.5 mg - Participants will receive H021, 12.5 mg oral tablet, as single-dose on Day 1 under fasting conditions.
Experimental: SAD Cohort 3: H021 25 mg - Participants will receive H021, 25 mg oral tablet, as single-dose on Day 1 under fasting conditions.
Experimental: SAD Cohort 4: H021 50 mg - Participants will receive H021, 50 mg oral tablet, as single-dose on Day 1 under fasting conditions.
Experimental: SAD Cohort 5: H021 100 mg - Participants will receive H021, 100 mg oral tablet, as single-dose on Day 1 under fasting conditions.
Experimental: MAD Cohort 6: H021 12.5 mg - Participants will receive H021, 12.5 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
Experimental: MAD Cohort 7: H021 25 mg - Participants will receive H021, 25 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
Experimental: MAD Cohort 8: H021 50 mg - Participants will receive H021, 50 mg oral tablet once daily from Day 1 to Day 7 under fasting conditions.
Placebo comparator: SAD-H021 Placebo - Participants will receive H021, placebo oral tablet, as single-dose on Day 1 under fasting or fed conditions.
Placebo comparator: MAD-H021 Placebo - Participants will receive H021, placebo oral tablet once daily from Day 1 to Day 7 under fasting conditions.
Treatment: Drugs: H021
H021 oral tablet.
Treatment: Drugs: H021 Placebo
H021 placebo oral tablet.
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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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Number of Participants with Adverse Events (AEs)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Any clinically significant changes in vital signs, electrocardiogram (ECG) measurement, physical examination and clinical laboratory parameters will be recorded as AE.
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Timepoint [1]
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Up to final follow-up (SAD Part: up to 8 days: MAD Part: up to 14 days)
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Secondary outcome [1]
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SAD Part: Area under the concentration-time curve from time zero until the last observed concentration (AUC0-t) of H021
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Assessment method [1]
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AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.
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Timepoint [1]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [2]
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SAD Part: Area under the concentration-time curve from time zero to infinity (AUC0-infinity) of H021
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Assessment method [2]
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AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).
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Timepoint [2]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [3]
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SAD Part: Maximal observed concentration (Cmax) of H021
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Assessment method [3]
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Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.
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Timepoint [3]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [4]
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SAD Part: Time to Reach Cmax (Tmax) of H021
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Assessment method [4]
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Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.
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Timepoint [4]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [5]
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SAD Part: Lag Time (Tlag) of H021
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Assessment method [5]
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Tlag is time of observation prior to the first observation with a measurable (non-zero) concentration (for food effect cohort only).
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Timepoint [5]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [6]
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SAD Part: Residual area of H021
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Assessment method [6]
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Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100.
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Timepoint [6]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24), and 48 hours post-dose
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Secondary outcome [7]
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SAD Part: Terminal elimination half-life (T1/2 el) of H021
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Assessment method [7]
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T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.
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Timepoint [7]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [8]
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SAD Part: Terminal elimination rate constant (Kel) of H021
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Assessment method [8]
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Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.
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Timepoint [8]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [9]
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SAD Part: Apparent clearance (CL/F) of H021
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Assessment method [9]
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CL/F is apparent total clearance of the drug from plasma after oral administration
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Timepoint [9]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [10]
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SAD Part: Apparent volume of distribution (Vz/F) of H021
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Assessment method [10]
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Vz/F is apparent volume of distribution during terminal phase after non-intravenous administration
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Timepoint [10]
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pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
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Secondary outcome [11]
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SAD Part: Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) of H021
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Assessment method [11]
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Ae0-t is defined as cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.
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Timepoint [11]
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pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
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Secondary outcome [12]
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SAD Part: Maximal Rate of Urinary Excretion (Rmax) of H021
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Assessment method [12]
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Rmax is defined as maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected.
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Timepoint [12]
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pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
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Secondary outcome [13]
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SAD Part: Time of Maximal Urinary Excretion (TRmax) of H021
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Assessment method [13]
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TRmax is defined as time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred.
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Timepoint [13]
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pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
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Secondary outcome [14]
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SAD Part: Renal Clearance (CLR) of H021
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Assessment method [14]
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CLR is renal clearance, calculated as Ae0-t /AUC0-t.
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Timepoint [14]
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pre-dose (spot; within 2 hours) and 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose
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Secondary outcome [15]
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MAD Part: Area under the concentration-time curve from time zero to time 24 hours (AUC0-24) of H021
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Assessment method [15]
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AUC0-24 is an area under the concentration-time curve from time zero to 24 hours post-dose.
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Timepoint [15]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [16]
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MAD Part: Cmax of H021
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Assessment method [16]
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Cmax is a measure of the maximum amount of drug in the plasma after the dose was given.
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Timepoint [16]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [17]
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MAD Part: Tmax of H021
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Assessment method [17]
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Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose was given.
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Timepoint [17]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [18]
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MAD Part: Area under the concentration-time curve for one dosing interval (t) at steady- state (AUC0-t) of H021
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Assessment method [18]
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AUC0-t is an area under the concentration-time curve for one dosing interval (t) at steady- state. In this study t = 24 hours (equivalent to AUC0-24) will be reported.
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Timepoint [18]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [19]
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MAD Part: Cmax ss of H021
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Assessment method [19]
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Cmax ss is a measure of the maximum amount of drug in the plasma at steady-state after the dose was given.
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Timepoint [19]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [20]
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MAD Part: Tmax ss of H021
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Assessment method [20]
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Tmax ss is a measure of the time to reach the maximum concentration in the plasma at steady state after the dose was given.
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Timepoint [20]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [21]
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MAD Part: Minimal observed concentration at steady-state (Cmin ss) of H021
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Assessment method [21]
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Cmin ss is minimal observed concentration at steady-state.
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Timepoint [21]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [22]
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MAD Part: AUC0-t of H021
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Assessment method [22]
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AUC0-t is an area under the concentration-time curve from time zero (pre-dose) to time of last observed concentration.
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Timepoint [22]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [23]
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MAD Part: AUC0-inf of H021
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Assessment method [23]
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AUC0-infinity is an area under the concentration-time curve from time zero to infinity (extrapolated).
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Timepoint [23]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [24]
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MAD Part: Residual area of H021
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Assessment method [24]
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Residual area is calculated as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-t/AUC0-inf)\] x 100.
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Timepoint [24]
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Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [25]
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MAD Part: T½ el of H021
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Assessment method [25]
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T1/2 el is defined as the duration until observation of half of the maximum concentration of drug dose.
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Timepoint [25]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [26]
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MAD Part: Kel of H021
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Assessment method [26]
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Kel is defined as first-order rate constant associated with the terminal (log-linear) portion of the curve.
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Timepoint [26]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [27]
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MAD Part: Apparent clearance at steady-state (Clss/F) of H021
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Assessment method [27]
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Clss/F is apparent clearance at steady-state.
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Timepoint [27]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [28]
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MAD Part: Apparent volume of distribution at steady-state (Vz ss/F) of H021
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Assessment method [28]
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Vz ss/F is apparent volume of distribution at steady-state.
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Timepoint [28]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [29]
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MAD Part: Accumulation ratio (RAUC)
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Assessment method [29]
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RAUC is accumulation ratio for AUC.
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Timepoint [29]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Secondary outcome [30]
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MAD Part: Accumulation Ratio (RCmax)
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Assessment method [30]
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RCmax is accumulation ratio for Cmax.
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Timepoint [30]
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0
Day 1 at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-first dose; predose on Days 4, 5, 6; Day 7 at pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours post-last dose
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Eligibility
Key inclusion criteria
1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (>=) 18 and less than and equal to (<=) 55 years of age, with body mass index (BMI) greater than (>)18.5 and less than (<) 32.0 kilograms per square meter (kg/m^2).
2. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
3. Female participants of non-childbearing potential must be:
1. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels >=40 milli-international units per milliliter (mIU/mL); or
2. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
4. Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
5. Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
6. Able to understand the study procedures and provide signed informed consent to participate in the study.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination.
2. Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB test at screening.
3. Positive pregnancy test or lactating female participant.
4. Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
5. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
6. Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolic blood pressure lower than 40 or over 90 mmHg, heart rate less than 40 or over 100 beats per minute (bpm), respiratory rate less than 10 or over 22 bpm), or oxygen saturation less than 95 percent (%) oxygen at screening.
7. History of drug abuse within 1 year prior to screening as determined by the investigator.
8. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 1 month prior to screening that exceeds 10 units of alcohol per week for women and men (1 unit = 375 [milliliter] mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
9. History of active tuberculosis or presence of active or latent tuberculosis. Previous latent tuberculosis that has been treated and is no longer active is not exclusionary.
10. History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
11. History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
12. Presence of fever (body temperature greater than (>) 37.5 degrees Celsius (°C) (example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
13. Use of medications within the timeframes specified.
14. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or simultaneous participation in an investigational study involving no drug or device administration.
15. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
16. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/02/2025
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
Nucleus Network Ply Ltd. - Melbourne
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Recruitment postcode(s) [1]
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0
3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Jiangsu Carephar Pharmaceutical Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy participants.
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Trial website
https://clinicaltrials.gov/study/NCT06627556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Dr. Ofer Gonen
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0385939801
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06627556
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