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

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)

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States
      • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alirocumab SAR236553 (REGN727) - Dose A; A single subcutaneous injection of Dose A	Drug: alirocumab SAR236553 (REGN727); Pharmaceutical form:Solution Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose B; A single subcutaneous injection of Dose B	Drug: alirocumab SAR236553 (REGN727); Pharmaceutical form:Solution Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain using present pain intensity (PPI) verbal questionnaire	6 weeks
Erythema at injection site by measuring diameter and qualitative assessment	6 weeks
Edema at injection site by measuring diameter and qualitative assessment	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of PK parameter - time to maximum concentration (tmax)	Up to 12 weeks
Assessment of PK parameter - maximum concentration (Cmax)	Up to 12 weeks
Assessment of PK parameter - area under curve (AUC)	Up to 12 weeks
Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)	Up to 12 weeks
Assessment of PK parameter - terminal elimination half-life (t1/2z)	Up to 12 weeks
Pharmacodynamics: Change in LDL-C from baseline	Up to 12 weeks
Number of participants with Adverse Events	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: PKD12010; U1111-1118-2935 (Other Identifier: UTN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No