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

NCT01448239 | Completed Phase 1

• 2 other identifiers: PKD12010U1111-1118-2935
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (2)

alirocumab SAR236553 (REGN727) - Dose A

EXPERIMENTAL

A single subcutaneous injection of Dose A

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - Dose B

EXPERIMENTAL

A single subcutaneous injection of Dose B

Drug: alirocumab SAR236553 (REGN727)

Interventions

alirocumab SAR236553 (REGN727) DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

alirocumab SAR236553 (REGN727) - Dose A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 7, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 28, 2013

Record last verified: 2012-02

Locations

US (1)