Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
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|ClinicalTrials.gov Identifier: NCT01265745|
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : December 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anthrax||Drug: Normal Saline for Injection Biological: MDX1303||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
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
- 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.
- Pharmacokinetics [ Time Frame: 133 days ]Evaluation of the pharmacokinetics/pharmacodynamics of Valortim in healthy human volunteers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265745
|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|