drugset
drugset / Trial / NCT05763576

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

NCT05763576 ↗

Phase 1 Terminated 60 enrolled Hoffmann-La Roche
RandomizedSequentialDouble-blindTreatment

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).

Timeline

Start
2023-04-28
Primary completion
2024-12-23
Completion
2024-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject RO7565020 Unknown — Subcutaneous
Background Entecavir Small molecule — Oral
Background Tenofovir disoproxil fumarate Small molecule — Oral
Background tenofovir alafenamide Small molecule — Oral

Indications

chronic hepatitis B virus infection