This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Hypercholesterolemia
and you are
between 20 and 65
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
Show me locations

The purpose

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.

Provided treatments

  • Drug: Alirocumab (Solution)
  • Drug: Alirocumab (Lyophilized formulation)
  • Drug: Placebo (Solution)
  • Drug: Placebo (Lyophilized formulation)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01448317. The sponsor of the trial is Sanofi and it is looking for 32 volunteers for the current phase.
Official trial title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects