Status:
COMPLETED
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
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
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Serum troponin I level should not exceed the upper laboratory limit of normal.
- Male or female subject, between 18 and 65 years inclusive.
- Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs after 10 minutes resting in supine position.
- Normal standard 12-lead ECG after 10 minutes resting in supine position.
- Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
- Serum LDL-C levels\>100 mg/dL at screening visit.
- Exclusion criteria:
- Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).
- Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). 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 (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.
- Fasting serum triglycerides \>200 mg/dL measured after an 8 to 12 hour fast.
- History of a hypersensitivity reaction to doxycycline or similar compound.
- 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 :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01448239
Start Date
February 1 2011
End Date
May 1 2011
Last Update
June 28 2013
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States