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

Sponsor
Sanofi
Study ID
NCT01785329
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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).

Key Dates

Start date
Feb 28, 2013
Status verified
Aug 2013
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: alirocumab SAR236553 (REGN727) - Dose A
    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)
  • Experimental: alirocumab SAR236553 (REGN727) - Dose B
    alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
  • Experimental: alirocumab SAR236553 (REGN727) - Dose C
    alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.

Primary Outcome Measure

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. [ Time Frame: Up to 12 weeks ]

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