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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: alirocumab SAR236553 (REGN727); Drug: placebo

• Registration Number: NCT02979015
• Lead Sponsor: Sanofi

Brief Summary

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

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 Timeline

• Study Start: 2016-11-29
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alirocumab	alirocumab SAR236553 (REGN727)	Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design
Placebo	placebo	Subcutaneous injection of a single dose of matching placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in other lipid parameters	Up to 12 weeks
Pharmacokinetics: Assessment of serum concentrations of alirocumab	Up to 12 weeks
Change from baseline in LDL-C	Up to 12 weeks
Pharmacokinetics: Assessment of serum concentrations of PCSK9	Up to 12 weeks

Trial Locations

Locations (1)

Investigational Site Number 156001; 🇨🇳 Beijing, China