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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: alirocumab SAR236553 (REGN727)

• Registration Number: NCT01785329
• Lead Sponsor: Sanofi

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2013-01-30
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alirocumab SAR236553 (REGN727) - Dose A	alirocumab SAR236553 (REGN727)	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)
alirocumab SAR236553 (REGN727) - Dose B	alirocumab SAR236553 (REGN727)	alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
alirocumab SAR236553 (REGN727) - Dose C	alirocumab SAR236553 (REGN727)	alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site Number 826001; 🇬🇧 London, United Kingdom