Status:
COMPLETED
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteer...
Eligibility Criteria
Inclusion
- Healthy men and women ages 18 to 65 years inclusive
- Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive
Exclusion
- Pregnant or breast-feeding women
- Any clinically significant abnormalities observed during screening (day -21 to day -2)
- Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
- History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
- Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
- Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
- History of a hypersensitivity reaction to doxycycline or similar compound
- Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
- Previous adverse experience to any biological investigational or therapeutic agent
- Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01893528
Start Date
June 1 2013
End Date
September 1 2014
Last Update
November 10 2014
Active Locations (2)
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1
Baltimore, Maryland, United States
2
Cincinnati, Ohio, United States