Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

• Status: Completed
• Trial end date: 2011-11-01
• 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 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.