NCT01742221

Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure

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 Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Neumedicines Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.

Detailed description

A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.

Conditions

• Hematopoietic Syndrome Due to Acute Radiation Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	HemaMax	single subcutaneous 12 microgram dose of HemaMax
DRUG	Placebo	single subcutaneous dose

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-12-05
• Last updated: 2018-11-16

Locations

1 site across 1 country: United States