Investigational Site Number 156001
Beijing, 100191, China
NCT Number: NCT02979015
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.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, 100191, China
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Time frame: Up to 12 weeks
Time frame: Up to 4 days
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Sanofi
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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