NCT04982991

Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants

A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants. Secondary Objective: To assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants

Detailed description

The duration of the study for a participant will be up to approximately 7 weeks and include: * Screening period: up to 4 weeks (Day -28 to Day -2). * Institutionalization period at each period of treatment: 4 days (Day -1 to Day 3, single SAR443820 administration on Day 1). * Wash-out period: at least 5 days between each dosing. * End-of-study visit: Period 3/ Day 6±1 day.

Conditions

• Multiple Sclerosis Healthy Subjects

Interventions

Type	Name	Description
DRUG	RIPK1 inhibitor	Capsule Oral

Timeline

• Start date: 2021-08-05
• Primary completion: 2021-10-11
• Completion: 2021-10-11
• First posted: 2021-07-29
• Last updated: 2022-04-25

Locations

1 site across 1 country: United Kingdom