Hypercholesterolemia
Conditions
Brief summary
Primary Objective: Injection Site Tolerability Secondary Objective: * To assess the safety profile of alirocumab SAR236553 (REGN727) * To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
Detailed description
The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.
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 at screening visit. * Male or female subject, between 18 and 65 years inclusive. * Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Normal vital signs after 10 minutes resting in supine position. * Normal standard 12-lead ECG after 10 minutes resting in supine position. * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects. * If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
Exclusion criteria
* Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C). * Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). 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 (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins. * Fasting serum triglycerides \>200 mg/dL measured after an 8 to 12 hour fast. * History of a hypersensitivity reaction to doxycycline or similar compound. 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 | 6 weeks |
| Erythema at injection site by measuring diameter and qualitative assessment | 6 weeks |
| Edema at injection site by measuring diameter and qualitative assessment | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29) | Up to 12 weeks |
| Assessment of PK parameter - terminal elimination half-life (t1/2z) | Up to 12 weeks |
| Assessment of PK parameter - time to maximum concentration (tmax) | Up to 12 weeks |
| Number of participants with Adverse Events | Up to 12 weeks |
| Pharmacodynamics: Change in LDL-C from baseline | Up to 12 weeks |
| Assessment of PK parameter - maximum concentration (Cmax) | Up to 12 weeks |
| Assessment of PK parameter - area under curve (AUC) | Up to 12 weeks |
Countries
United States
Outcome results
None listed