Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Valortim is the name of the experimental drug that volunteers will receive in this study.
Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by
the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made
immune system molecule) for the treatment of inhalation anthrax (when the infection starts in
the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the
toxin from doing damage to cells. This study is being conducted to see if Valortim given over
120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase,
Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the
time when you receive the study medication), Follow-up Phase (the time after you receive the
study medication) and Final Visit.
Phase:
Phase 1
Details
Lead Sponsor:
PharmAthene, Inc.
Collaborators:
Department of Health and Human Services National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)