Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To assess the safety and tolerability of ascending single doses of subcutaneously (SC)
administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.
Secondary Objectives:
- To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum
low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as
total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density
lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides,
Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
- To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
- To assess the immunogenicity of a single SC dose of alirocumab.