Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: alirocumab SAR236553 (REGN727)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448239

U1111-1118-2935 (Other Identifier)

PKD12010

Details and patient eligibility

About

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)

Full description

The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

alirocumab SAR236553 (REGN727) - Dose A

Experimental group

Description:

A single subcutaneous injection of Dose A

Treatment:

Drug: alirocumab SAR236553 (REGN727)

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - Dose B

Experimental group

Description:

A single subcutaneous injection of Dose B

Treatment:

Drug: alirocumab SAR236553 (REGN727)

Drug: alirocumab SAR236553 (REGN727)