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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01209793
Collaborator
Sanofi (Industry)
40
Enrollment
1
Location
5
Arms
10
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: REGN846
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, 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
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of adverse events [Baseline through end of study]

Secondary Outcome Measures

  1. PK profile [Baseline through end of study]

  2. Immunogenicity [Visits 2, 8, 10 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Nucleus Network Melbourne Australia

Sponsors and Collaborators

  • Regeneron Pharmaceuticals
  • Sanofi

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01209793
Other Study ID Numbers:
  • R846-HV-1007
First Posted:
Sep 27, 2010
Last Update Posted:
Jun 1, 2012
Last Verified:
May 1, 2012

Study Results

No Results Posted as of Jun 1, 2012