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OpenTrials
Completed

NCT Number: NCT01785329

Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously 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).

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 826001

London, NW10 7EW, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alirocumab SAR236553 (REGN727)

Drug

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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