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

August 16, 2013 updated by: Sanofi

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW10 7EW
        • Investigational Site Number 826001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose B
alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose C
alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: Up to 12 weeks
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.
Time Frame: Up to 12 weeks
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.
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDR13362
  • 2012-005005-40
  • U1111-1134-2618 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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