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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Multiple Sclerosis Healthy Subjects

Intervention / Treatment
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* Drug: RIPK1 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: East Asian (Chinese and Japanese) male and/or female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent. Chinese or Japanese ethnicity, according to the following criteria: Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China. Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG. Body weight within 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, and body mass index (BMI) within the range 18.0 and 30.0 kg/m2, inclusive. Exclusion Criteria: Medical history of any seizure. Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any live attenuated vaccine given within 3 months or any non-live vaccine given within 2 weeks before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion. Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test. Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the Columbia-Suicide Severity Rating Scale [C-SSRS]), or a lifetime suicide attempt. A yes response to questions 4 or 5 on the Suicidal Ideation section, or a score of 4 or 5 on the Intensity of Ideation section of the baseline/screening version of the C-SSRS at screening, or on the Since Last Visit version of the C-SSRS at baseline. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR443820<br>Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods | Drug: RIPK1 inhibitor<br>* Capsule Oral<br>* Other names: SAR443820;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic (PK) parameter: Cmax | Maximum plasma concentration | Up to day 3 | 
| Assessment of pharmacokinetic (PK) parameter: AUClast | Area under the plasma concentration versus time curve from time zero to the real time last | Up to day 3 | 
| Assessment of pharmacokinetic (PK) parameter: AUC | Area under the plasma concentration versus time curve | Up to day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events (AEs) | Number of participants with Adverse events | Up to day 21 |