Status:
COMPLETED
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01209793
Start Date
November 1 2010
End Date
September 1 2011
Last Update
June 1 2012
Active Locations (1)
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1
Nucleus Network
Melbourne, Australia