NCT Number: NCT01893528
Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Baltimore, Maryland, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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.
Treatment and study plan
Placebo
OtherPrimary outcomes
-
Number of TEAEs
Time frame: day 1 to day 106/ visit 15
The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jul 9, 2013
- Registry last updated
- Nov 10, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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