NCT05858788

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

A Phase 1, Open Label, 3-treatment Period, 1-sequence, Cross-over Study to Evaluate Pharmacokinetics, Safety, and Tolerability After Single Ascending Oral Doses of SAR441566 in Healthy Adult Japanese Male Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.

Detailed description

The duration of the study for a participant will be up to approximately 65 days.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SAR441566	Tablet

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2023-05-15
• Last updated: 2025-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study