A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria: Healthy volunteers: Healthy participants Body mass index (BMI) between 18 and 32 kg/m^2 CHB participants: CHB infection (HBsAg-positive for >/= 6 months) On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis BMI between 18 and 32 kg/m^2 Exclusion Criteria: Healthy volunteers: History of any clinically significant disease Concomitant disease that could interfere with treatment or conduct of study Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer) CHB participants: Evidence of liver cirrhosis or decompensated liver disease History or suspicion of hepatocellular carcinoma (HCC) History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during the study.
Sites / Locations
- Inland Empire Liver FoundationRecruiting
- Quest Clinical ResearchRecruiting
- New Zealand Clinical Research - AucklandRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
RO7565020
Placebo