NCT03570658

A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants

A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety and tolerability of RO7049389 compared to placebo in single- and multiple-ascending doses in healthy Chinese participants.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	RO7049389	RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).
DRUG	Placebo	Placebo will be administered orally at a dose and frequency matched to RO7049389.

Timeline

• Start date: 2018-08-24
• Primary completion: 2019-01-28
• Completion: 2019-01-28
• First posted: 2018-06-27
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

1 site across 1 country: China