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Clinical Trial 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).


Clinical Trial Description

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


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01785329
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date February 2013
Completion date July 2013

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