RO7565020 PHASE I STUDY IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH CHRONIC HEPATITIS B
Research type
Research Study
Full title
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
IRAS ID
1007505
Contact name
Head of CTRM Regulatory Affairs, Clinical Trial Regulatory Management, Product Development Regulatory,
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
Research summary
Chronic hepatitis B (CHB) virus infection is a major global healthcare problem, with an estimated prevalence of 296 million people. The current standard of care are possibly lifelong treatments which provide a functional cure in rare cases.
Patients aged between 18 and 65 who have been diagnosed with CHB virus infection are being invited to participate in this study. The experimental study drug, RO7565020, is being developed for the possible treatment of CHB. It is a human origin monoclonal antibody. The purpose of the study is to find out what good or bad effects the experimental study treatment has on the participant and how it is distributed and eliminated from their body.
One hospital in the UK is participating, and eligible participants will be placed in one group in Part 2 or Part 3 of this study. All participants will receive the study treatment but the dose and dosing regimen might differ. Participants in part 2 will receive RO7565020 once given as an injection in the fatty area under the skin. Participants in part 3 will receive multiple doses of RO7565020 given as injections.
The duration of the study will be up to 64 weeks (16 months) for Part 2 participants and up to 112 weeks (2 years and 2 months) for Part 3 participants. Part 2 participants will attend the hospital for 12 to 16 visits. Part 3 participants will attend for several assessment visits before attending 11 to 15 schedule visits. Blood and urine samples will be collected and ECG will be performed at several time points during their participation in the study.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0634
Date of REC Opinion
24 Oct 2023
REC opinion
Further Information Unfavourable Opinion