The trial is taking place at:
Q

Quest Clinical Research | San Francisco, CA

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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

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Roche

Status and phase

Enrolling
Phase 1

Conditions

Chronic Hepatitis B

Treatments

Drug: Nucleos(t)ide analogue (NUC) treatment
Drug: RO7565020
Other: Placebo

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

110 participants in 2 patient groups, including a placebo group

RO7565020
Experimental group
Treatment:
Drug: RO7565020
Drug: Nucleos(t)ide analogue (NUC) treatment
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

14

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Central trial contact

Reference Study ID Number: BP44118 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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