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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-22

Study results available
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Summary

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

Interventions

DRUG

RO7565020

RO7565020 will be administered by subcutaneous injection or intravenous infusion.

OTHER

Placebo

Matching placebo will be administered by subcutaneous injection or intravenous infusion.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2024-12-23
Completion
2024-12-23
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • New Zealand
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763576 on ClinicalTrials.gov