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)
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Pharmaceutical form:Solution Route of administration: Subcutaneous
Pharmaceutical form:Solution Route of administration: Subcutaneous
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Pain using present pain intensity (PPI) verbal questionnaire
Time frame: 6 weeks
Erythema at injection site by measuring diameter and qualitative assessment
Time frame: 6 weeks
Edema at injection site by measuring diameter and qualitative assessment
Time frame: 6 weeks
Assessment of PK parameter - time to maximum concentration (tmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - maximum concentration (Cmax)
Time frame: Up to 12 weeks
Assessment of PK parameter - area under curve (AUC)
Time frame: Up to 12 weeks
Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)
Time frame: Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Time frame: Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline
Time frame: Up to 12 weeks
Number of participants with Adverse Events
Time frame: Up to 12 weeks
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