Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

December 5, 2013 updated by: Sanofi

A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects

Primary Objective:

To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose

Secondary Objective:

To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of the study for each subject is 8-11 weeks broken down as follows:

  • Screening: 2 to 21 days,
  • Treatment: 1 day (2 overnight stays at the study site),
  • Follow-up: up to 2 months after dosing.

Study Type

Interventional

Enrollment (Actual)

30

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
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Investigational Site Number 840001

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Healthy male and female subjects between 18 and 45 years of age

Exclusion criteria:

  • Presence or history of drug hypersensitivity or allergic disease
  • History or presence of dermatological disorders
  • Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
  • Prior opportunistic infections within 6 months before inclusion
  • History or presence of listeriosis or tuberculosis
  • Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
  • Any biologics given within 4 months before inclusion
  • Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening

The above information is not intended to contain all considerations relevant to a subject'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: SAR231893 (REGN668) Drug Product (DP) 1
SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection
Biological: SAR231893 (REGN668) DP1
Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: SAR231893 (REGN668) Drug Product (DP) 2
SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection
Biological: SAR231893 (REGN668) DP2
Pharmaceutical form:solution Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of serum concentrations of SAR231893 (REGN668)
Time Frame: Up to 57 Days
Up to 57 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain evaluation at injection site using Visual Analog Scale (VAS)
Time Frame: Up to 8 Days
Up to 8 Days
Erythema at injection site by measuring diameter
Time Frame: Up to 8 Days
Up to 8 Days
Edema at injection site by measuring diameter
Time Frame: Up to 8 Days
Up to 8 Days
Number of participants experiencing adverse events
Time Frame: Up to 57 Days
Up to 57 Days

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKM12350
  • U1111-1119-3152 (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.

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