NCT05763576TerminatedPhase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 28 Feb 2023
- Start date
- 28 Apr 2023
- Primary completion date
- 23 Dec 2024
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Hepatitis B
- NCT number
- NCT05763576
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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.
Other illness
- History of any clinically significant disease
- Evidence of liver cirrhosis or decompensated liver disease
- 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
Other
- Healthy volunteers:
- History or suspicion of hepatocellular carcinoma (HCC)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin, New Territories | Hong Kong | Unknown status |
| Hallym University Chuncheon Sacred Heart Hospital Coordinator of this site? Confirm its status | Chuncheon | South Korea | Unknown status |
| New Zealand Clinical Research - Auckland Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Faculty of Medicine Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Chang Gung Medical Foundation Linkou Branch Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Quest Clinical Research Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.