A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2017-11-27
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects.

Secondary Objectives:

• To assess the pharmacokinetic profile of a single SC dose of alirocumab.

• To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters.

• To assess the immunogenicity of a single SC dose of alirocumab.

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

Details

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

Criteria

Inclusion criteria:

• Healthy male or female subjects.

• Aged 18 to 45 years old.

• Low-density lipoprotein cholesterol >100 mg/dL (2.59 mmol/L).

Exclusion criteria:

• Subjects with any history or presence of clinically relevant illness.

• Serum triglycerides >200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.

• Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.