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

June 27, 2013 updated by: Sanofi

A Randomized Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Different Single-Dose Subcutaneous Treatments of SAR236553/REGN727 in Healthy Subjects

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

Intervention / Treatment

Detailed Description

Total duration for each subject (not including screening) will be approximately 85 days.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Serum LDL-C levels >100 mg/dL.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 1)
A single subcutaneous injection of Formulation A
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: alirocumab SAR236553 (REGN727) (Formulation B x 1)
A single subcutaneous injection of Formulation B
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 2)
2 single subcutaneous injections of Formulation A
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 and Visual Analog Scale (VAS)
Time Frame: 15 days
15 days
Erythema at injection site by measuring diameter and qualitative assessment
Time Frame: 15 days
15 days
Edema at injection site by measuring diameter and qualitative assessment
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of PK parameter - time to maximum concentration (tmax)
Time Frame: Up to 85 days
Up to 85 days
Pharmacodynamics: Change in LDL-C from baseline
Time Frame: Up to 85 days
Up to 85 days
Number of participants with Adverse Events
Time Frame: Up to 85 days
Up to 85 days
Assessment of PK parameter - maximum concentration (Cmax)
Time Frame: Up to 85 days
Up to 85 days
Assessment of PK parameter - area under curve (AUC)
Time Frame: Up to 85 days
Up to 85 days
Assessment of PK parameter - area under curve versus time curve (AUC0-D29)
Time Frame: Zero to Day 29
Zero to Day 29
Assessment of PK parameter - plasma concentration on Day 29 (C D29)
Time Frame: Day 29
Day 29
Assessment of PK parameter - terminal elimination half-life (t1/2z)
Time Frame: Up to 85 days
Up to 85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 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

Other Study ID Numbers

  • PKD12275
  • U1111-1120-0670 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on alirocumab SAR236553 (REGN727)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe