Hematopoietic Syndrome Due to Acute Radiation Syndrome Clinical Trial
Official title:
A Phase 2 Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects
The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.
This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01742221 -
Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
|
Phase 1 |