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.
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous
Sanofi-Aventis Administrative Office
Tokyo, Japan
Number of participants with Adverse Events
Time frame: 106 days
Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.
Time frame: 106 days
Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.
Time frame: 106 days
Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.
Time frame: 106 days
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