At a glance
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A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-week Treatment of Patients With Chronic Hepatitis B Virus Infection
In Brief
A Phase 1 clinical trial evaluating Placebo and RO7020531 for Hepatitis B, Chronic. Completed, enrolled 160 participants across 18 sites in 8 countries.
Detailed Summary
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.
Study Details
Timeline
Interventions
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
RO7020531 will be administered as per schedule specified in the respective arm.