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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: alirocumab SAR236553 (REGN727); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02979015

U1111-1133-7871 (Other Identifier)

PKD13404

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

35 participants in 2 patient groups, including a placebo group

Alirocumab

Experimental group

Description:

Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design

Treatment:

Drug: alirocumab SAR236553 (REGN727)

Placebo

Placebo Comparator group

Description:

Subcutaneous injection of a single dose of matching placebo

Treatment:

Drug: placebo