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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01785329
First received: January 30, 2013
Last updated: August 16, 2013
Last verified: August 2013

January 30, 2013
August 16, 2013
February 2013
July 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
Assessment of the serum concentrations of 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01785329 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of the number of subjects with adverse events after a single subcutaneous administration of SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects
A Randomized Study of the Relative Bioavailability, Pharmacodynamics, Safety of SAR236553 (REGN727) After Single Subcutaneous Administration at 3 Different Injection Sites in Healthy Subjects

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).

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
  • 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)

    Intervention: Drug: alirocumab SAR236553 (REGN727)
  • Experimental: alirocumab SAR236553 (REGN727) - Dose B
    alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
    Intervention: Drug: alirocumab SAR236553 (REGN727)
  • Experimental: alirocumab SAR236553 (REGN727) - Dose C
    alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.
    Intervention: Drug: alirocumab SAR236553 (REGN727)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2013
July 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01785329
BDR13362, 2012-005005-40, U1111-1134-2618
No
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP