28
Participants
Start Date
December 31, 2010
Primary Completion Date
August 31, 2011
Study Completion Date
December 31, 2011
Normal Saline for Injection
Equivalent amounts to subjects weight, once over 120 minutes
MDX1303
a sterile solution at a protein concentration of 25 mg/mL: 20 mM sodium citrate, 50 mM sodium chloride, 3.0% mannitol, 50 µM diethylenetriamine pentacetic acid and 0.06% polysorbate 80 at pH 6.5. A tubular, clear glass vial, filled with a 5 mL dose of colorless to pale yellow solution. The vial is sealed with a 20 mm stopper and white flip-off seal.
Quintiles Phase I Unit, Overland Park
Lead Sponsor
Department of Health and Human Services
FED
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Institutes of Health (NIH)
NIH
PharmAthene, Inc.
INDUSTRY