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

Study Overview
=================
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.

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

Official 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.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: SAR441566


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR441566<br>Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle | Drug: SAR441566<br>* Tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs) | Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest | Up to end of study visit (which will occur at latest day 37 of study) |