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).
Total duration of the study per subject is about 15 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
60
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Investigational Site Number 826001
London, United Kingdom
Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product.
Time frame: Up to 12 weeks
Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product.
Time frame: Up to 12 weeks
Assessment of the number of subjects with adverse events after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product.
Time frame: Up to 12 weeks
Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of alirocumab SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product.
Time frame: Up to 12 weeks
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