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

NCT02979015

CompletedPhase 1

Sponsor: Sanofi

Conditions: Hypercholesterolemia

Interventions: alirocumab SAR236553 (REGN727), placebo

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Beijing, China