Clinical Trial: Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Neumedicines Inc.

Current Primary Outcome: Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability) [ 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:

  • Pharmacokinetics of HemaMax (AUC, Cmax and Tmax) [ Time Frame: 3 months ]
    PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure
  • Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response) [ Time Frame: 3 months ]
    IFN-g and CXCL-10 induction as a measure of pharmacodynamic response
  • Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity) [ Time Frame: 3 months ]
    Anti-drug antibodies as a measure of immunogenicity


Original Secondary Outcome: Same as current

Information By: Neumedicines Inc.

Dates:
Date Received: January 13, 2015
Date Started: January 2015
Date Completion:
Last Updated: August 2, 2016
Last Verified: August 2016