Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

Study Overview
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Brief Summary
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Primary Objective: To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects. Secondary Objectives: To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins. To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727). To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).

Detailed Description
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Total duration of the study per subject is about 15 weeks.

Official Title
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A Randomized Study of the Relative Bioavailability, Pharmacodynamics, Safety of SAR236553 (REGN727) After Single Subcutaneous Administration at 3 Different Injection Sites in Healthy Subjects

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: alirocumab SAR236553 (REGN727)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy subjects. Exclusion criteria: Healthy subjects with history or presence of clinically relevant illness. 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: 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alirocumab SAR236553 (REGN727) - Dose A<br>alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen. alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) | Drug: alirocumab SAR236553 (REGN727)<br>* Pharmaceutical form:Solution for injection Route of administration: Subcutaneous<br>|
| Experimental: alirocumab SAR236553 (REGN727) - Dose B<br>alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm. | Drug: alirocumab SAR236553 (REGN727)<br>* Pharmaceutical form:Solution for injection Route of administration: Subcutaneous<br>|
| Experimental: alirocumab SAR236553 (REGN727) - Dose C<br>alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh. | Drug: alirocumab SAR236553 (REGN727)<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 |
| --- | --- | --- |
| Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. |  | Up to 12 weeks | 
| Assessment of the number of subjects with adverse events after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. |  | Up to 12 weeks | 
| Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of alirocumab SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. |  | Up to 12 weeks |