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NCT Number: NCT05858788

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International-Site Number:8400001

Glendale, California, 91206, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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
  • Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Treatment and study plan

SAR441566

Drug

Tablet

Primary outcomes

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

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

    Maximum plasma concentration observed

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

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

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

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

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

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

Secondary outcomes

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

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

    Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 15, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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