A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
NCT ID: NCT05763576
Last Updated: 2026-01-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
60 participants
INTERVENTIONAL
2023-04-28
2024-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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RO7565020
RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
Nucleos(t)ide analogue (NUC) treatment
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
Placebo
Placebo
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Interventions
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RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
Placebo
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Nucleos(t)ide analogue (NUC) treatment
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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, , Taiwan
Faculty of Medicine Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EU Trial Number
Identifier Type: REGISTRY
Identifier Source: secondary_id
BP44118
Identifier Type: -
Identifier Source: org_study_id
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