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

NCT ID: NCT01448304

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

alirocumab SAR236553 (REGN727) - Dose A

A single subcutaneous injection of Dose A

Group Type: EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

alirocumab SAR236553 (REGN727) - Dose B

A single subcutaneous injection of Dose B

Group Type: EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

Interventions

alirocumab SAR236553 (REGN727)

Pharmaceutical form:Solution Route of administration: Subcutaneous

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

U1111-1119-3056

Identifier Type: OTHER

Identifier Source: secondary_id

PKD12011

Identifier Type: -

Identifier Source: org_study_id