Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: 133 days ] [ Designated as safety issue: Yes ]
- 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.
- Pharmacokinetics [ Time Frame: 133 days ] [ Designated as safety issue: No ]Evaluation of the pharmacokinetics/pharmacodynamics of Valortim in healthy human volunteers
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Valortim
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.
Placebo Comparator: Placebo
Saline solution will be used as the placebo
Drug: Normal Saline for Injection
Equivalent amounts to subjects weight, once over 120 minutes
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.
|United States, Kansas|
|Quintiles Phase I Unit|
|Overland Park, Kansas, United States, 66223|
|Principal Investigator:||Ralph Schutz, MD||Quintiles Phase I Services|
|Study Director:||Valeire D Riddle, MD||Sponsor Medical Monitor|