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

NCT05858788 | Completed Phase 1 FDA Drug

• 2 other identifiers: PKM17860U1111-1287-6944
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax

  Maximum plasma concentration observed

  From Day 1 to Day 5 of each period (5 days per period)

• Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast

  Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)

  From Day 1 to Day 5 of each period (5 days per period)

• Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC

  Area under the plasma concentration versus time curve extrapolated to infinity (AUC)

  From Day 1 to Day 5 of each period (5 days per period)

Secondary Outcomes (1)

• Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)

  Up to end of study visit (which will occur at latest day 37 of study)

Study Arms (1)

SAR441566

EXPERIMENTAL

Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle

Drug: SAR441566

Interventions

SAR441566 DRUG

Tablet

SAR441566

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan.
• Male participants between the ages of 18 and 55 years, inclusive
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests)
• Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness.
• Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study.
• History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test.
• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Parexel International-Site Number:8400001

Glendale, California, 91206, United States

Location

Related Links

• PKM17860 Plain Language Results Summary

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 15, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)