Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
- Registration Number
- NCT01448239
- Lead Sponsor
- Sanofi
- Brief Summary
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)
- Detailed Description
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description alirocumab SAR236553 (REGN727) - Dose B alirocumab SAR236553 (REGN727) A single subcutaneous injection of Dose B alirocumab SAR236553 (REGN727) - Dose A alirocumab SAR236553 (REGN727) A single subcutaneous injection of Dose A
- Primary Outcome Measures
Name Time Method Pain using present pain intensity (PPI) verbal questionnaire 6 weeks Erythema at injection site by measuring diameter and qualitative assessment 6 weeks Edema at injection site by measuring diameter and qualitative assessment 6 weeks
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events Up to 12 weeks Assessment of PK parameter - time to maximum concentration (tmax) Up to 12 weeks Assessment of PK parameter - maximum concentration (Cmax) Up to 12 weeks Assessment of PK parameter - area under curve (AUC) Up to 12 weeks Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29) Up to 12 weeks Assessment of PK parameter - terminal elimination half-life (t1/2z) Up to 12 weeks Pharmacodynamics: Change in LDL-C from baseline Up to 12 weeks
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇸Bridgewater, New Jersey, United States