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

NCT05763576

TerminatedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Chronic Hepatitis B

Interventions: RO7565020, Placebo, Nucleos(t)ide analogue (NUC) treatment

Countries: United States, Hong Kong, New Zealand, South Korea, Spain, Taiwan, Thailand

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (9)

San Francisco, California, United States
Hong Kong, Hong Kong
Shatin, New Territories, Hong Kong
Auckland, New Zealand
Chuncheon, South Korea
Vigo, Pontevedra, Spain
Taoyuan City, Taiwan
Bangkok, Thailand
Chiang Mai, Thailand