NCT05763576

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

• Chronic Hepatitis B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-28
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2023-03-10
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

9 sites across 7 countries: United States, Hong Kong, New Zealand, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study