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 ]

Number of subjects with adverse events as a measure of safety and tolerability


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 ]

To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.


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