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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: alirocumab SAR236553 (REGN727)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alirocumab<br>Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design | Drug: alirocumab SAR236553 (REGN727)<br>* Pharmaceutical form: Solution for injection Route of administration: Subcutaneous<br>|
| Placebo Comparator: Placebo<br>Subcutaneous injection of a single dose of matching placebo | Drug: placebo<br>* Pharmaceutical form: Solution for injection Route of administration: Subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests |  | Up to 12 weeks | 
| Incidence of injection site reactions |  | Up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in LDL-C |  | Up to 12 weeks | 
| Change from baseline in other lipid parameters |  | Up to 12 weeks | 
| Pharmacokinetics: Assessment of serum concentrations of alirocumab |  | Up to 12 weeks | 
| Pharmacokinetics: Assessment of serum concentrations of PCSK9 |  | Up to 12 weeks |