NCT03530917

A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.

A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020531 and Metabolites Following Oral Administration to Chinese Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	RO7020531	4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.
DRUG	Placebo	Placebo hard capsules will be administered orally as per the dosing schedules described above.

Timeline

• Start date: 2018-05-15
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2018-05-21
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

1 site across 1 country: Hong Kong