Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

Study Overview
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Brief Summary
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Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose

Detailed Description
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The duration of the study for each subject is 8-11 weeks broken down as follows: Screening: 2 to 21 days, Treatment: 1 day (2 overnight stays at the study site), Follow-up: up to 2 months after dosing.

Official Title
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A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: SAR231893 (REGN668) DP1
* Biological: SAR231893 (REGN668) DP2


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male and female subjects between 18 and 45 years of age Exclusion criteria: Presence or history of drug hypersensitivity or allergic disease History or presence of dermatological disorders Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections Prior opportunistic infections within 6 months before inclusion History or presence of listeriosis or tuberculosis Any vaccination within 3 months (1 month for influenza vaccine) before inclusion Any biologics given within 4 months before inclusion Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR231893 (REGN668) Drug Product (DP) 1<br>SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection | Biological: SAR231893 (REGN668) DP1<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|
| Experimental: SAR231893 (REGN668) Drug Product (DP) 2<br>SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection | Biological: SAR231893 (REGN668) DP2<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of serum concentrations of SAR231893 (REGN668) |  | Up to 57 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation at injection site using Visual Analog Scale (VAS) |  | Up to 8 Days | 
| Erythema at injection site by measuring diameter |  | Up to 8 Days | 
| Edema at injection site by measuring diameter |  | Up to 8 Days | 
| Number of participants experiencing adverse events |  | Up to 57 Days |