Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
Completed · Phase 1
Conditions studied: Hypercholesterolemia
In brief
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)
Key facts
- Study ID
- NCT01448239
- Run by
- Sanofi
- People needed
- 24
- Starts
- 2011-02-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-06-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Serum troponin I level should not exceed the upper laboratory limit of normal.
- 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.
- Serum LDL-C levels>100 mg/dL at screening visit.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
Full record on ClinicalTrials.gov
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