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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01537640
First received: February 17, 2012
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Biological: SAR231893 (REGN668) DP1
Biological: SAR231893 (REGN668) DP2
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of serum concentrations of SAR231893 (REGN668) [ Time Frame: Up to 57 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain evaluation at injection site using Visual Analog Scale (VAS) [ Time Frame: Up to 8 Days ] [ Designated as safety issue: Yes ]
  • Erythema at injection site by measuring diameter [ Time Frame: Up to 8 Days ] [ Designated as safety issue: Yes ]
  • Edema at injection site by measuring diameter [ Time Frame: Up to 8 Days ] [ Designated as safety issue: Yes ]
  • Number of participants experiencing adverse events [ Time Frame: Up to 57 Days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537640

Locations
United States, Florida
Investigational Site Number 840001
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01537640     History of Changes
Other Study ID Numbers: PKM12350, U1111-1119-3152
Study First Received: February 17, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013