Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

NCT01443650 | Completed Phase 1

• 2 other identifiers: PKD12275U1111-1120-0670
• Study Type: interventional
• Target: 36
• 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 and Visual Analog Scale (VAS)

  15 days

• Erythema at injection site by measuring diameter and qualitative assessment

  15 days

• Edema at injection site by measuring diameter and qualitative assessment

  15 days

Secondary Outcomes (8)

• Assessment of PK parameter - time to maximum concentration (tmax)

  Up to 85 days

• Pharmacodynamics: Change in LDL-C from baseline

  Up to 85 days

• Number of participants with Adverse Events

  Up to 85 days

• Assessment of PK parameter - maximum concentration (Cmax)

  Up to 85 days

• Assessment of PK parameter - area under curve (AUC)

  Up to 85 days

Study Arms (3)

alirocumab SAR236553 (REGN727) (Formulation A x 1)

EXPERIMENTAL

A single subcutaneous injection of Formulation A

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) (Formulation B x 1)

EXPERIMENTAL

A single subcutaneous injection of Formulation B

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) (Formulation A x 2)

EXPERIMENTAL

2 single subcutaneous injections of Formulation A

Drug: alirocumab SAR236553 (REGN727)

Interventions

alirocumab SAR236553 (REGN727) DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

alirocumab SAR236553 (REGN727) (Formulation A x 1); alirocumab SAR236553 (REGN727) (Formulation A x 2); alirocumab SAR236553 (REGN727) (Formulation B x 1)

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 LDL-C levels \>100 mg/dL.

You may not qualify if:

• Subjects indicated for the use of statins according to criteria in Adult Treatment Program (ATP) III Guidelines, as updated in 2004.
• Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening. 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, including but not limited to statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid resins, or red yeast rice.
• Fasting serum triglycerides \>200 mg/dL measured after an 8-12 hour fast.
• 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: September 21, 2011
• First Posted: September 30, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 28, 2013

Record last verified: 2012-02

Locations

US (1)