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

Roche

Status and phase

Enrolling

Phase 1

Conditions

Chronic Hepatitis B

Treatments

Drug: RO7565020

Other: Placebo

Drug: Nucleos(t)ide analogue (NUC) treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT05763576

BP44118

EU Trial Number (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

110 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.