Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Sponsor
Sanofi
Study ID
NCT01448317
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Alirocumab (Solution) — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Alirocumab (Lyophilized formulation) — DRUG
    Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous
  • Placebo (Solution) — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Placebo (Lyophilized formulation) — DRUG
    Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous

Study Details

Primary Objective: To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects. Secondary Objectives: * To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a). * To assess the Pharmacokinetic profile of a single SC dose of alirocumab. * To assess the immunogenicity of a single SC dose of alirocumab.

Key Dates

Start date
May 31, 2011
Status verified
Sep 2016
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: Cohort 1
    Alirocumab dose 1 versus placebo
  • Experimental: Cohort 2
    Alirocumab dose 2 versus placebo
  • Experimental: Cohort 3
    Alirocumab dose 3 versus placebo
  • Experimental: Cohort 4
    Alirocumab dose 4 versus placebo

Primary Outcome Measure

Number of participants with Adverse Events [ Time Frame: 106 days ]

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