A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
About the study
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chronic Hepatitis B
Age (in years)
18 - 65
Phase
Phase 1
Participants needed
110
Est. Completion Date
Feb 1, 2027
Treatment type
Interventional
Sponsor
Hoffmann-La Roche
ClinicalTrials.gov identifier
NCT05763576
Study number
BP44118
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