NCT02343133

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Neumedicines Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	HemaMax
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-01-21
• Last updated: 2018-11-16

Locations

4 sites across 1 country: United States