Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects

Study Overview
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Brief Summary
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Primary objective: To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects. Secondary objectives: To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously. To assess the safety of the different SAR153191 drug products administered subcutaneously.

Detailed Description
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Up to 35 Days

Official Title
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Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses, in Healthy Male Subjects

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SAR153191-P3 drug product
* Drug: SAR153191-P2 drug product
* Drug: SAR153191-C1F3 drug product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. 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: 65 Years

Sexes Eligible for Study
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Male

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>SAR153191 - P3 drug product concentration 1 dose 1 | Drug: SAR153191-P3 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Experimental: Group B<br>SAR153191 - P2 drug product concentration 2 dose 2 | Drug: SAR153191-P2 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Experimental: Group C<br>SAR153191 - P3 drug product concentration 2 dose 2 | Drug: SAR153191-P3 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Experimental: Group D<br>SAR153191 - P3 drug product concentration 3 dose 3 | Drug: SAR153191-P3 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Experimental: Group B'<br>SAR153191 - P2 drug product concentration 2 dose 3 | Drug: SAR153191-P2 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Experimental: Group C'<br>SAR153191 - P3 drug product concentration 2 dose 3 | Drug: SAR153191-P3 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|
| Active Comparator: Group E'<br>SAR153191 - CIF3 drug product concentration 2 dose 3 | Drug: SAR153191-C1F3 drug product<br>* Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection<br>* Other names: SAR153191;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting injection site reactions | Injection site reactions include pain, erythema an edema. | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Cmax | Maximum plasma concentration observed | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration | 
| Pharmacokinetics: tmax | First time to reach Cmax | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration | 
| Pharmacokinetics: AUClast | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration | 
| Pharmacokinetics: AUC | Area under the plasma concentration versus time curve extrapolated to infinity | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration | 
| Pharmacokinetics: t1/2z | Terminal half-life associated with the terminal slope (λz) | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration | 
| Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI) |  | Up to 35 Days | 
| Incidence of anti-SAR153191 antibodies |  | At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive) |