NCT02956850

A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
OTHER	Placebo	Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
DRUG	RO7020531	RO7020531 will be administered as per schedule specified in the respective arm.

Timeline

• Start date: 2016-12-12
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2016-11-07
• Last updated: 2024-02-08
• Results posted: 2024-02-08

Locations

18 sites across 8 countries: Bulgaria, Hong Kong, Italy, Netherlands, New Zealand, Taiwan, Thailand, United Kingdom