Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

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.