Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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 volunteers.
Key facts
- Study ID
- NCT01893528
- Run by
- Regeneron Pharmaceuticals
- People needed
- 49
- Starts
- 2013-06-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2014-11-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Study site — Baltimore, Maryland, United States
- Study site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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