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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02952924
Registration number
NCT02952924
Ethics application status
Date submitted
1/11/2016
Date registered
2/11/2016
Date last updated
31/10/2024
Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
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Scientific title
A Safety, Tolerability, Pharmacokinetics and Efficacy Study of ro7049389 in: (1) Single- (With or Without Food) and Multiple- (With Midazolam) Ascending Doses in Healthy Volunteers; (2) Patients Chronically Infected With Hepatitis b Virus (3) Patients With Chronic Hepatitis B.
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Secondary ID [1]
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YP39364
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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:
Hepatitis B, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Midazolam
Other interventions - Placebo
Treatment: Drugs - RO7049389
Placebo comparator: Parts 1a and 1b: SAD in Healthy Volunteers (Placebo) - In Part 1a, participants will receive a single oral dose of placebo matching to RO7049389 film coated tablet on Day 1. In Part 1b, minimum 8 participants from Part 1a will be selected and 2 of whom will receive another single dose of placebo matching to RO7049389 on Day 16 after eating the standard United States - Food and Drug Administration (US FDA)-recommended high-fat and high-calorie breakfast.
Experimental: Parts 1a and 1b: SAD in Healthy Volunteers (RO7049389) - In Part 1a, participants will receive a single oral dose of RO7049389 film coated tablet on Day 1 in dose-escalation cohorts with a starting dose of 150 milligrams (mg). The doses for subsequent cohorts will be defined by an adaptive approach based on the safety and PK data in previously-dosed healthy volunteers. In Part 1b, minimum 8 participants from Part 1a will be selected and 6 of whom will receive another single dose of RO7049389 on Day 16 after eating the standard US FDA-recommended high-fat and high-calorie breakfast.
Placebo comparator: Part 1c: MAD in Healthy Volunteers (Placebo) - Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 13 (either once a day \[QD\] or twice a day \[BID\]) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 micrograms \[mcg\]) on Day -1 and Day 14.
Experimental: Part 1c: MAD in Healthy Volunteers (RO7049389) - Participants will receive RO7049389 film coated tablet from Days 1 to 13 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 mcg) on Day -1 and Day 14.
Placebo comparator: Part 2: POM in Chronic HBV Participants (Placebo) - Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 27 (either QD or BID) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 28.
Experimental: Part 2: POM in Chronic HBV Participants (RO7049389) - Participants will receive RO7049389 film coated tablet from Days 1 to 27 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 28.
Experimental: Part 3: POM in NUC-Suppressed CHB Participants (Cohort A) - Participants will receive RO7049389 on top of a NUC for 48 weeks at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines.
Experimental: Part 3: POM in Treatment-Naive CHB Participants (Cohort B) - Participants will receive RO7049389 for 4 weeks, followed by RO7049389 with an added NUC for 44 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC therapy will be administered per local label or guidelines.
Experimental: Part 3: POM in Treatment-Naive CHB Participants (Cohort C) - Participants will receive RO7049389 + NUC + Pegylated-Interferon (Peg-IFN) for 48 weeks. RO7049389 will be administered at a dose determined from Part 2. NUC and Peg-IFN therapy will be administered per local label or guidelines.
Treatment: Drugs: Midazolam
Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo
Other interventions: Placebo
Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
Treatment: Drugs: RO7049389
RO7049389 will be administered as per schedule described in individual arm.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 1: Percentage of Participants With Adverse Events
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Assessment method [1]
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Timepoint [1]
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Up to Day 29 (Part 1a), Day 44 (Part 1b), Day 42 (Part 1c)
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Primary outcome [2]
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Parts 1a and 1b: SAD Cohort: Time to Reach Maximum Concentration (Tmax) of RO7049389
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Assessment method [2]
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Timepoint [2]
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Up to 28 days
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Primary outcome [3]
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Parts 1a and 1b: SAD Cohort: Maximum Observed Plasma Concentration (Cmax) of RO7049389
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Assessment method [3]
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Timepoint [3]
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Up to 28 days
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Primary outcome [4]
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Parts 1a and 1b: SAD Cohort: AUC From Time Zero to Infinity (AUC0-inf) of RO7049389
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Assessment method [4]
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Timepoint [4]
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Up to 28 days
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Primary outcome [5]
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Parts 1a and 1b: SAD Cohort: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of RO7049389
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Assessment method [5]
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Timepoint [5]
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Up to 28 days
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Primary outcome [6]
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Parts 1a and 1b: SAD Cohort: Half-life (T1/2) of RO7049389
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Assessment method [6]
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Timepoint [6]
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Up to Day 28
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Primary outcome [7]
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Parts 1a and 1b: SAD Cohort: Apparent Oral Clearance (CL/F) of RO7049389
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Assessment method [7]
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Timepoint [7]
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Up to Day 28
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Primary outcome [8]
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Parts 1a and 1b: SAD Cohort: Cumulative Amount Excreted Unchanged in Urine (Ae) of RO7049389
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Assessment method [8]
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Timepoint [8]
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Up to Day 28
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Primary outcome [9]
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Parts 1a and 1b: SAD Cohort: Renal Clearance (CLr) of RO7049389
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Assessment method [9]
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Timepoint [9]
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Up to Day 28
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Primary outcome [10]
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Part 2: Percentage of Participants With Adverse Events
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Assessment method [10]
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Timepoint [10]
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Up to Day 112
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Primary outcome [11]
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Part 2: Quantitative Plasma HBV DNA Level
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Assessment method [11]
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Timepoint [11]
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Baseline - Day 112
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Primary outcome [12]
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Part 3: Proportion of Patients Achieving Functional Cure
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Assessment method [12]
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Functional cure is defined as HBV DNA \< lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (\< 0.05 IU/mL) at 24 weeks post-treatment.
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Timepoint [12]
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Every 2-4 weeks from Baseline through Week 72
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Secondary outcome [1]
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Part 1b: Food Effect on Cmax of RO7049389
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Assessment method [1]
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This outcome measure evaluated the effect of food on the pharmacokinetics (PK) of RO7049389 after the administration of a single dose. Participants were fed a high-fat, high-calorie breakfast (per FDA food effect bioavailability and bioequivalence study recommendations) 30 minutes prior to dosing after fasting overnight for at least 8 hours. ANOVA (factors fasted/fed state and subject) was performed for measurements available in subjects in both fasted and fed states.
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Timepoint [1]
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Day 16
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Secondary outcome [2]
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Part 1b: Food Effect on AUCinf of RO7049389
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Assessment method [2]
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This outcome measure evaluated the effect of food on the pharmacokinetics (PK) of RO7049389 after the administration of a single dose. Participants were fed a high-fat, high-calorie breakfast (per FDA food effect bioavailability and bioequivalence study recommendations) 30 minutes prior to dosing after fasting overnight for at least 8 hours. ANOVA (factors fasted/fed state and subject) was performed for measurements available in subjects in both fasted and fed states.
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Timepoint [2]
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Day 16
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Secondary outcome [3]
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Part 1c: Cmax of Midazolam
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Assessment method [3]
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This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).
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Timepoint [3]
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Up to Day 14
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Secondary outcome [4]
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Part 1c: AUCinf of Midazolam
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Assessment method [4]
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This endpoint presents the geometric mean ratio (after RO7049389/before RO7049389).
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Timepoint [4]
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Up to Day 14
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Secondary outcome [5]
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Part 1c: Tmax of RO7049389
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Assessment method [5]
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Timepoint [5]
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Up to Day 14
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Secondary outcome [6]
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Part 1c: Cmax of RO7049389
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Assessment method [6]
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Timepoint [6]
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Up to Day 14
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Secondary outcome [7]
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Part 1c: AUC0-12hr of RO7049389
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Assessment method [7]
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Timepoint [7]
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Up to Day 14
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Secondary outcome [8]
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Part 1c: CLr of RO7049389
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Assessment method [8]
0
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Timepoint [8]
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Up to Day 14
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Secondary outcome [9]
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Part 1c: Accumulation Ratio of RO7049389
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Assessment method [9]
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This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 14) within each arm.
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Timepoint [9]
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Day 1, Day 14
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Secondary outcome [10]
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Part 1c: T1/2 of RO7049389
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Assessment method [10]
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Timepoint [10]
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Up to Day 14
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Secondary outcome [11]
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Part 1c: Ae of RO7049389
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Assessment method [11]
0
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Timepoint [11]
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Up to Day 14
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Secondary outcome [12]
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Part 1c: Ctrough of RO7049389
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Assessment method [12]
0
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Timepoint [12]
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Up to Day 14
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Secondary outcome [13]
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Part 2: HBV DNA < Lower Limit of Quantification (LLOQ)
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Assessment method [13]
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Timepoint [13]
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Baseline - Day 112/Follow-up Day 84
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Secondary outcome [14]
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Part 2: Tmax of RO7049389
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Assessment method [14]
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Timepoint [14]
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Up to Day 28
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Secondary outcome [15]
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Part 2: Cmax of RO7049389
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Assessment method [15]
0
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Timepoint [15]
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Up to Day 28
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Secondary outcome [16]
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Part 2: AUCtau of RO7049389
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Assessment method [16]
0
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Timepoint [16]
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Up to Day 28
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Secondary outcome [17]
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Part 2: Accumulation Ratio of RO7049389
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Assessment method [17]
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This endpoint presents the geometric mean ratio of AUC after a single dose (Day 1) and AUC after having received multiple doses (Day 28) within each arm.
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Timepoint [17]
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Day 1, Day 28
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Secondary outcome [18]
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Part 2: T1/2 of RO7049389
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Assessment method [18]
0
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Timepoint [18]
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Up to Day 28
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Secondary outcome [19]
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Part 2: Ctrough of RO7049389
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Assessment method [19]
0
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Timepoint [19]
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Up to Day 28
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Secondary outcome [20]
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Part 3: Percentage of Participants With AEs
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Assessment method [20]
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Timepoint [20]
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72 weeks
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Secondary outcome [21]
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Part 3: Hepatitis B Surface Antigen (HBsAg) Level
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Assessment method [21]
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Timepoint [21]
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Baseline - Week 72
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Secondary outcome [22]
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Part 3: Hepatitis B e-Antigen (HBeAg) Levels
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Assessment method [22]
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Timepoint [22]
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Baseline - Week 72
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Secondary outcome [23]
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Part 3: HBV RNA Level
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Assessment method [23]
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Timepoint [23]
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Baseline - Week 72
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Secondary outcome [24]
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Part 3: HBV Core-Related Antigen (HBcrAg) Levels
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Assessment method [24]
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Timepoint [24]
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Baseline - Week 72
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Secondary outcome [25]
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Part 3: Alanine Transaminase (ALT) Normalization in Participants With Baseline ALT Elevation
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Assessment method [25]
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Timepoint [25]
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Week 12 - Week 72
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Secondary outcome [26]
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Part 3: Percentage of Participants With Anti-Hepatitis B Core Antigen (HBc) Antibodies
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Assessment method [26]
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Timepoint [26]
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Up to Week 72
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Secondary outcome [27]
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Part 3: HBV DNA Level
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Assessment method [27]
0
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Timepoint [27]
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Baseline - Week 72
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Secondary outcome [28]
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Part 3: HBV DNA < Lower Limit of Quantification (LLOQ)
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Assessment method [28]
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Timepoint [28]
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Baseline - Week 72
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Secondary outcome [29]
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Part 3: Tmax of RO7049389
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Assessment method [29]
0
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Timepoint [29]
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Day 1 - Week 48
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Secondary outcome [30]
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Part 3: Cmax of RO7049389
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Assessment method [30]
0
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Timepoint [30]
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Day 1 - Week 48
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Secondary outcome [31]
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Part 3: AUCtau of RO7049389
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Assessment method [31]
0
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Timepoint [31]
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Day 1 - Week 48
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Secondary outcome [32]
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Part 3: T1/2 of RO7049389
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Assessment method [32]
0
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Timepoint [32]
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Day 1 - Week 48
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Eligibility
Key inclusion criteria
Part 1- Healthy Volunteers only:
* Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead Electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
* A Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive
* Female participants must be either surgically sterile or post-menopausal for at least one year
* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Part 2- Chronic HBV-infected participants only:
* A BMI between 18 to 30 kg/m^2 inclusive
* Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization
* HBV DNA at screening greater than or equal to (>/=) 2 × 10^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or >/=2 × 10^3 IU/mL for HBeAg-negative participants
* Liver biopsy, fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis
* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
* For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods that result in a failure rate of less than (<)1 percent (%) per year during the treatment period and for at least 3 months after the last dose of study drug
Part 3- Chronic HBV Participants Only:
* A BMI between 18 to 32 kg/m^2 inclusive
* Chronic hepatitis B infection, defined as positive test for HBsAg or HBV DNA, or positive HBeAg, for more than 6 months prior to screening
* For Cohorts only enrolling NUC-suppressed CHB participants (e.g. POM Cohort A), participants must have been treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for at least 12 months. Participants must be on the same NUC therapy for at least 3 months prior to screening
* For Cohorts only enrolling anti-HBV treatment-naive and immune-active participants (e.g. POM Cohort B and Cohort C), previous anti-HBV treatments <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose
* Liver biopsy, fibroscan, or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis
* For men: agreement to remain abstinent or use contraceptive measures, and agree to refrain from donating sperm
* For women of childbearing potential: agreement to remain abstinent or to use two approved contraceptive methods during the study and for at least 6 months after the last dose of study drug
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Minimum age
18
Years
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Maximum age
60
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
Part 1- Healthy Volunteers only:
* History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* History of Gilbert's syndrome
* Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies
* Any clinically significant concomitant diseases or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
* Positive test at screening of any of the following: Hepatitis A (HAV IgM Ab), Hepatitis B (HBsAg), Hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus (HIV Ab)
* Acute narrow-angle glaucoma (for MAD-midazolam cohorts)
Part 2- Chronic HBV-infected participants only:
* History or other evidence of bleeding from esophageal varices
* Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy
* History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steatohepatitis, etc.)
* Documented history or other evidence of metabolic liver disease within one year of randomization
* Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, or human immunodeficiency virus
* History of or suspicion of hepatocellular carcinoma or alphafetoprotein >/= Upper limit of normal (ULN) at screening
* History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease
* History of organ transplantation
* Previous or concurrent HBV treatments in the past 6 months
* Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization
Part 3- Chronic Hepatitis B Participants Only:
* History or other evidence of bleeding from esophageal varices
* Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, or hepatic encephalopathy
* History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic statohepatitis, etc.)
* History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests
* Documented history or other evidence of metabolic liver disease within one year of screening
* Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, HEV, or HIV
* Diagnosed or suspected hepatocellular carcinoma
* History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric, or neurological disease
* History of organ transplantation
* Significant acute infection (e.g. influenza, local infection) or any other clinically significant illness within 2 weeks of screening
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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 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
Completed
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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
14/12/2016
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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
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Actual
16/03/2022
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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0
Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [2]
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0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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0
4029 - Herston
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Recruitment postcode(s) [2]
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0
3050 - Parkville
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Recruitment outside Australia
Country [1]
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0
Bulgaria
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State/province [1]
0
0
Sofia
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Country [2]
0
0
China
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State/province [2]
0
0
Guangzhou
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Country [3]
0
0
China
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State/province [3]
0
0
Shanghai City
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Country [4]
0
0
China
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State/province [4]
0
0
Shanghai
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Country [5]
0
0
Hong Kong
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State/province [5]
0
0
Hong Kong
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Country [6]
0
0
Hong Kong
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State/province [6]
0
0
Shatin, New Territories
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Country [7]
0
0
New Zealand
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State/province [7]
0
0
Auckland
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Country [8]
0
0
New Zealand
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State/province [8]
0
0
Grafton
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Country [9]
0
0
Singapore
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State/province [9]
0
0
Singapore
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Country [10]
0
0
Taiwan
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State/province [10]
0
0
Kaohsiung City
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Country [11]
0
0
Taiwan
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State/province [11]
0
0
Kaohsiung
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Country [12]
0
0
Taiwan
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State/province [12]
0
0
Taichung
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Country [13]
0
0
Taiwan
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State/province [13]
0
0
Tainan
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Country [14]
0
0
Taiwan
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State/province [14]
0
0
Taipei City
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Country [15]
0
0
Taiwan
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State/province [15]
0
0
Taipei
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Country [16]
0
0
Thailand
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State/province [16]
0
0
Bangkok
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Country [17]
0
0
Thailand
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State/province [17]
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0
Chiang Mai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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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
This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label part to assess the efficacy and safety of RO7049389 when administered in combination with standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and treatment-naive chronic hepatitis B (CHB) participants.
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Trial website
https://clinicaltrials.gov/study/NCT02952924
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Trial related presentations / publications
Yuen MF, Zhou X, Gane E, Schwabe C, Tanwandee T, Feng S, Jin Y, Triyatni M, Lemenuel-Diot A, Cosson V, Xue Z, Kazma R, Bo Q. Safety, pharmacokinetics, and antiviral activity of RO7049389, a core protein allosteric modulator, in patients with chronic hepatitis B virus infection: a multicentre, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):723-732. doi: 10.1016/S2468-1253(21)00176-X. Epub 2021 Jul 6. Feng S, Gane E, Schwabe C, Zhu M, Triyatni M, Zhou J, Bo Q, Jin Y. A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e01323-20. doi: 10.1128/AAC.01323-20. Print 2020 Oct 20.
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Public notes
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Contacts
Principal investigator
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Hoffmann-La Roche
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What supporting documents are/will be available?
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Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT02952924/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT02952924/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02952924
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