Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects

A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects

Primary Objective:

To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).

Secondary Objectives:

• To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
• To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.

Total duration of the study per subject (excluding screening) is about 22 weeks.

Inclusion criteria :

• Healthy male /or female subjects,
• aged 18 to 65 years old,
• with LDL-C > 130 mg/dL
• not receiving lipid lowering therapy.

Exclusion criteria:

• Healthy subjects with history or presence of clinically relevant illness.
• Subjects currently taking statins, ezetimibe or fenofibrate.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.