A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT05763576
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description RO7565020 RO7565020 - RO7565020 Nucleos(t)ide analogue (NUC) treatment - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Healthy Volunteers With Adverse Events Up to 104 weeks Percentage of Participants With Chronic Hepatitis B With Adverse Events Up to 104 weeks
- Secondary Outcome Measures
Name Time Method Serum Concentrations of RO7565020 Up to 104 weeks Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg) Up to 104 weeks Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints Up to 104 weeks Percentage of Participants With HBsAg Loss Up to 104 weeks Percentage of Participants With HBsAg Seroconversion Up to 104 weeks Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline Up to 104 weeks Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline Up to 104 weeks
Trial Locations
- Locations (12)
Quest Clinical Research
🇺🇸San Francisco, California, United States
Hôpital Saint-Antoine
🇫🇷Paris, France
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
New Zealand Clinical Research - Auckland
🇳🇿Auckland, New Zealand
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Chang Gung Medical Foundation Linkou Branch
🇨🇳Taoyuan City, Taiwan
Taichung Veterans General Hospital
🇨🇳Xitun Dist., Taiwan
Faculty of Medicine Siriraj Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Thailand