Status:
COMPLETED
Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Detailed Description
Total duration for each subject (not including screening) will be approximately 85 days.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Serum LDL-C levels \>100 mg/dL.
- Exclusion criteria:
- Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.
- Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. Subjects must be willing to maintain a consistent diet for the duration of the study.
- Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.
- Fasting serum triglycerides \>200 mg/dL measured after an 8-12 hour fast.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01443650
Start Date
July 1 2011
End Date
November 1 2011
Last Update
June 28 2013
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States