First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

Study Overview
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Brief Summary
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Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)

Detailed Description
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Study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of SAR441255 in Lean to Overweight Adult Subjects

Conditions
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Overweight, Healthy Subjects

Intervention / Treatment
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* Drug: SAR441255
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Male and female subjects, between 18 and 55 years of age, inclusive Body Mass Index ≥20 and ≤30 kg/m2 Body weight between 65 and 90 kg, inclusive No concomitant medication Fasting Plasma Glucose <126 mg/dL Hemoglobin A1c <6.5% Triglycerides <300 mg/dL Low-density lipoprotein (LDL) Cholesterol <200 mg/dL Permanent sterile or postmenopausal, if female Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness. Any medication (including over the counter products and any other herbal/alternative remedies such as 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 vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. 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: 18 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
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR441255<br>Single dose, subcutaneous, escalating dose | Drug: SAR441255<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|
| Placebo Comparator: Placebo<br>Single dose, subcutaneous, matched volume | Drug: placebo<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Screening to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic (PK) parameter: Cmax | Maximum plasma concentration | Baseline to 96 hrs | 
| Assessment of PK parameter: AUC | Area under the plasma concentration versus time curve (AUC) | Baseline to 96 hrs | 
| Assessment of PK parameter: tmax | Time to reach Cmax | Baseline to 96 hrs | 
| Assessment of pharmacodynamics (PD): glucose profile | Change from baseline in glucose profile | Baseline to 24 hrs | 
| Assessment of PD: insulin profile | Change from baseline in insulin profile | Baseline to 24 hrs | 
| Assessment of PD: C-peptide profile | Change from baseline in C-peptide profile | Baseline to 24 hrs |