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

Phase 2

Completed

• Conditions: Hematopoietic Syndrome Due to Acute Radiation Syndrome
• Interventions: Drug: Placebo; Biological: HemaMax

• Registration Number: NCT02343133
• Lead Sponsor: Neumedicines Inc.

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 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-21
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria

• ≥18 to ≤75 years of age
• Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
• Normal ECG, vital signs and laboratory test results
• Use of effective birth control method and abstinence from sex
• Negative pregnancy test and drug screen

Exclusion Criteria

Subjects with any of the following characteristics will be considered ineligible:

• History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease
• Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)
• Drug or alcohol addiction
• History of clinically significant allergy of any kind
• Prior use of IL-12 or HemaMax
• Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single subcutaneous dose
HemaMax	HemaMax	Single subcutaneous 12 microgram dose of HemaMax

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)	3 months	Number of subjects with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States