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

Sponsor
Sanofi
Study ID
NCT02979015
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • alirocumab SAR236553 (REGN727) — DRUG
    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
  • placebo — DRUG
    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Study Details

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.

Key Dates

Start date
Nov 29, 2016
Status verified
Dec 2017
Primary completion
Nov 27, 2017
Completion
Nov 27, 2017

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design
  • Placebo Comparator: Placebo
    Subcutaneous injection of a single dose of matching placebo

Primary Outcome Measure

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 ]

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