Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)
- Registration Number
- NCT01448304
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description alirocumab SAR236553 (REGN727) - Dose A alirocumab SAR236553 (REGN727) A single subcutaneous injection of Dose A alirocumab SAR236553 (REGN727) - Dose B alirocumab SAR236553 (REGN727) A single subcutaneous injection of Dose B
- Primary Outcome Measures
Name Time Method Pain using present pain intensity (PPI) verbal questionnaire 6 weeks Edema at injection site by measuring diameter and qualitative assessment 6 weeks Erythema at injection site by measuring diameter and qualitative assessment 6 weeks
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter - time to maximum concentration (tmax) 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 Number of participants with Adverse Events Up to 12 weeks 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 Pharmacodynamics: Change in LDL-C from baseline Up to 12 weeks
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇺🇸Bridgewater, New Jersey, United States