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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hematopoietic Syndrome Due to Acute Radiation Syndrome

Intervention / Treatment
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* Biological: HemaMax
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HemaMax<br>Single subcutaneous 12 microgram dose of HemaMax | Biological: HemaMax<br> <br> * Other names: rHuIL-12, NM-IL-12;|
| Placebo Comparator: Placebo<br>Single subcutaneous dose | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability) | Number of subjects with adverse events as a measure of safety and tolerability | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HemaMax, NM-IL-12, HSARS, Safety