Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)

Completed · Phase 1

Conditions studied: Hypercholesterolemia

In brief

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)

Key facts

Study ID

NCT01448304

Run by

Sanofi

People needed

24

Starts

2011-06-01

Expected to finish

2011-09-01

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 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.

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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