Primary Objective: Injection Site Tolerability Secondary Objectives: * To assess the safety profile of alirocumab SAR236553 (REGN727) * To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
Total duration for each subject (not including screening) will be approximately 85 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Pharmaceutical form:solution Route of administration: subcutaneous
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)
Time frame: 15 days
Erythema at injection site by measuring diameter and qualitative assessment
Time frame: 15 days
Edema at injection site by measuring diameter and qualitative assessment
Time frame: 15 days
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 85 days
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 85 days
Number of participants with Adverse Events
Time frame: Up to 85 days
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 85 days
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 85 days
Assessment of PK parameter - area under curve versus time curve (AUC0-D29)
Time frame: Zero to Day 29
Assessment of PK parameter - plasma concentration on Day 29 (C D29)
Time frame: Day 29
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Time frame: Up to 85 days
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