Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01209793
First received: September 24, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.


Condition Intervention Phase
Healthy
Biological: REGN846
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Baseline through end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK profile [ Time Frame: Baseline through end of study ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Visits 2, 8, 10 and 12 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
(3:1, active: placebo)
Biological: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)
Experimental: Dose 2
(3:1, active: placebo)
Biological: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)
Experimental: Dose 3
(3:1, active: placebo)
Biological: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)
Experimental: Dose 4
(3:1, active: placebo)
Biological: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)
Experimental: Dose 5
(3:1, active: placebo)
Biological: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
  • Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
  • Normal vital signs after resting in a sitting position for 5 minutes:
  • Normal standard 12-lead ECG
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Able to understand and complete study-related questionnaires

Exclusion Criteria:

  • Current or prior history of smoking
  • Any illness or condition that would adversely affect the subject's participation in this study
  • Hospitalization within 60 days of the screening visit
  • Any clinically significant abnormalities observed during the screening visit
  • History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  • History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
  • History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
  • Known sensitivity to any of the components of the Investigational Product formulation
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
  • Any condition that would place the subject at risk, interfere with participation in the study
  • History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
  • Live/attenuated vaccinations within 12 weeks of screening or during the study
  • Any subjects with planned elective surgery
  • Sexually active men who are unwilling to utilize adequate contraception
  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: NCT01209793

Locations
Australia
Nucleus Network
Melbourne, Australia
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01209793     History of Changes
Other Study ID Numbers: R846-HV-1007
Study First Received: September 24, 2010
Last Updated: May 31, 2012
Health Authority: Australia: National Health and Medical Research Council
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 28, 2014