A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

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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).

Conditions:

Chronic Hepatitis B

Study Start (Actual) 2023-04-28

Primary Completion (Estimated) 2026-05-13

Study Completion (Estimated) 2026-05-13

Enrollment (Estimated) 110

Study Type INTERVENTIONAL

Phase PHASE1

Locations:

📍 Rialto, California, United States

📍 San Francisco, California, United States

📍 Sofia, Bulgaria

📍 Clichy cedex, France

📍 Paris, France

📍 Hong Kong, Hong Kong

📍 Shatin, New Territories, Hong Kong

📍 Chuncheon, Korea, Republic of

📍 Seoul, Korea, Republic of

📍 Auckland, New Zealand

📍 Vigo, Pontevedra, Spain

📍 Taoyuan City, Taiwan

📍 Xitun Dist., Taiwan

📍 Bangkok, Thailand

📍 Chiang Mai, Thailand

More locations available...

Eligibility Criteria

Description

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:

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.

Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-02-28
First Submitted that Met QC Criteria2023-02-28
First Posted2023-03-10

Study Record Updates

Last Update Submitted that Met QC Criteria2024-07-04
Last Update Posted2024-07-08
Last Verified2024-07