Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2011
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.
Epistemonikos ID: ecc23b24a6ff765da144dc1200182c9dfe0aa10a
First added on: May 10, 2024