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: December 5, 2013
Last verified: July 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014