Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
| Status: | Archived |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | December 2011 |
A Phase I, Double-blind, Randomized, Placebo Controlled, Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) as a 120 Minute Infusion in Healthy, Normal Subjects
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.
Twenty-eight subjects will be recruited and entered into one of three dose groups 1mg/kg,
5mg/kg, 10mg/kg or placebo. Subjects will be stagger dosed into one of the three groups and
randomly assigned to receive Valortim or saline. Subjects will reside in the clinical trial
Phase I Unit from Day -1 through Day 2. After discharge on Day 2, all subjects will return
to the Phase I unit 7 times at specified time points over an additional 130 days post-dosing
(133 days total participation from check-in on Day -1)or placebo.
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