Hypercholesterolemia
Conditions
Brief summary
Primary Objective: Injection Site Tolerability Secondary Objectives: * To assess the safety profile of alirocumab SAR236553 (REGN727) * To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
Detailed description
Total duration for each subject (not including screening) will be approximately 85 days.
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Serum LDL-C levels \>100 mg/dL.
Exclusion criteria
* Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004. * Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. Subjects must be willing to maintain a consistent diet for the duration of the study. * Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice. * Fasting serum triglycerides \>200 mg/dL measured after an 8-12 hour fast. 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 |
|---|---|
| Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS) | 15 days |
| Erythema at injection site by measuring diameter and qualitative assessment | 15 days |
| Edema at injection site by measuring diameter and qualitative assessment | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PK parameter - maximum concentration (Cmax) | Up to 85 days |
| Assessment of PK parameter - area under curve (AUC) | Up to 85 days |
| Assessment of PK parameter - time to maximum concentration (tmax) | Up to 85 days |
| Assessment of PK parameter - plasma concentration on Day 29 (C D29) | Day 29 |
| Assessment of PK parameter - terminal elimination half-life (t1/2z) | Up to 85 days |
| Assessment of PK parameter - area under curve versus time curve (AUC0-D29) | Zero to Day 29 |
| Pharmacodynamics: Change in LDL-C from baseline | Up to 85 days |
| Number of participants with Adverse Events | Up to 85 days |
Countries
United States
Outcome results
None listed