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

Sanofi35 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

alirocumab SAR236553 (REGN727)DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

placeboDRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Investigational Site Number 156001

Beijing, China

Outcomes

Primary Outcomes

Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests

Time frame: Up to 12 weeks

Incidence of injection site reactions

Time frame: Up to 4 days

Secondary Outcomes

Change from baseline in LDL-C

Time frame: Up to 12 weeks

Change from baseline in other lipid parameters

Time frame: Up to 12 weeks

Pharmacokinetics: Assessment of serum concentrations of alirocumab

Time frame: Up to 12 weeks

Pharmacokinetics: Assessment of serum concentrations of PCSK9

Time frame: Up to 12 weeks

Data from ClinicalTrials.gov

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