Overview

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

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Criteria
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.