A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Chronic Hepatitis B
In brief
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).
Key facts
- Study ID
- NCT05763576
- Run by
- Hoffmann-La Roche
- People needed
- 60
- Starts
- 2023-04-28
- Expected to finish
- 2024-12-23
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Quest Clinical Research — San Francisco, California, United States
- Queen Mary Hospital — Hong Kong, Hong Kong
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong
- New Zealand Clinical Research - Auckland — Auckland, New Zealand
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea
- Hospital Alvaro Cunqueiro — Vigo, Pontevedra, Spain
- Chang Gung Medical Foundation Linkou Branch — Taoyuan City, Taiwan
- Faculty of Medicine Siriraj Hospital — Bangkok, Thailand
- Maharaj Nakorn Chiang Mai Hospital — Chiang Mai, Thailand
Full record on ClinicalTrials.gov
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