Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects
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.
Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period). ;
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