At a glance
ClinicalIndex Comparison Record- ✓Healthy volunteers (Part 1): BMI 18–30 kg/m² and body weight ≥50 kg
- ✓CHB participants (Parts 2a/2b): Positive HBsAg >6 months prior and titer ≥10³ IU/mL at screening
- ✓CHB participants (Parts 2a/2b): On entecavir, tenofovir, adefovir, or telbivudine ≥6 months with HBV DNA ≤90 IU/mL for preceding 6 months
- ✓CHB participants (Parts 2a/2b): Liver imaging (biopsy, fibroscan, or equivalent) within 6 months showing chronic HBV without bridging fibrosis or cirrhosis
- ✕Healthy volunteers (Part 1): Positive HBV, HCV, or HIV; recent drug/alcohol abuse (6 months); positive drug/alcohol/cotinine screening
- ✕CHB participants (Parts 2a/2b/2c): History of esophageal variceal bleeding or decompensated liver disease
- ✕CHB participants (Parts 2a/2b): Hepatocellular carcinoma or AFP ≥13 ng/mL; other chronic liver disease etiology; hepatitis D co-infection
- ✕CHB participants (Parts 2a/2b): Positive HAV IgM, HCV, or HIV; organ transplant; abnormal renal function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Sponsor-Open, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of RO7062931 With Single Ascending Doses in Healthy Volunteers and Multiple Doses and Modified Regimens in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
In Brief
A Phase 1 clinical trial evaluating RO7062931, Placebo, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 119 participants across 19 sites in 7 countries.
Detailed Summary
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.
Study Details
Timeline
Interventions
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.