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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary: 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.
Sponsor: PharmAthene, Inc.

Current Primary Outcome: Safety [ Time Frame: 133 days ]

  • Determination of changes from baseline for clinical laboratory tests and urinalysis, body temperature, heart rate, blood pressure, respiratory rate, physical examination and electrocardiogram (ECG).
  • Occurrence and evaluation of adverse events and serious adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pharmacokinetics [ Time Frame: 133 days ]

Evaluation of the pharmacokinetics/pharmacodynamics of Valortim in healthy human volunteers


Original Secondary Outcome: Same as current

Information By: PharmAthene, Inc.

Dates:
Date Received: December 17, 2010
Date Started: December 2010
Date Completion:
Last Updated: December 6, 2013
Last Verified: December 2013