Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal