Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

August 31, 2011

Study Completion Date

December 31, 2011

Conditions
Anthrax
Interventions
DRUG

Normal Saline for Injection

Equivalent amounts to subjects weight, once over 120 minutes

BIOLOGICAL

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.

Trial Locations (1)

66223

Quintiles Phase I Unit, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Department of Health and Human Services

FED

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

PharmAthene, Inc.

INDUSTRY

NCT01265745 - Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects | Biotech Hunter | Biotech Hunter