Hypercholesterolemia
Conditions
Brief summary
Primary Objective: To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects. Secondary Objectives: * To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins. * To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727). * To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
Detailed description
Total duration of the study per subject is about 15 weeks.
Interventions
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects.
Exclusion criteria
Healthy subjects with history or presence of clinically relevant illness. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. | Up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. | Up to 12 weeks |
| Assessment of the number of subjects with adverse events after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. | Up to 12 weeks |
| Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of alirocumab SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. | Up to 12 weeks |
Countries
United Kingdom
Outcome results
None listed