Clinical Trial: Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1b, Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subject
Brief Summary: This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.
Detailed Summary:
Sponsor: Neumedicines Inc.
Current Primary Outcome: To determine the safety and tolerability of HemaMax in healthy subjects. [ Time Frame: 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects [ Time Frame: 3 months ]
Original Secondary Outcome: Same as current
Information By: Neumedicines Inc.
Dates:
Date Received: August 6, 2012
Date Started: August 2012
Date Completion:
Last Updated: April 25, 2013
Last Verified: April 2013