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

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).

Timeline

Start

2013-02

Primary completion

2013-07

Completion

2013-07

Publications

• Lunven C, Paehler T, Poitiers F, Brunet A, Rey J, Hanotin C, Sasiela WJ. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014 Dec;32(6):297-301. doi: 10.1111/1755-5922.12093.

Drugs

Indications