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

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

Detailed Description
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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.

Official Title
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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

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 subjects, who have signed the informed consent form must meet all of the following criteria 18 to 45 years of age Body mass index (BMI) > 19 and < 0 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) Current 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: 45 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>* single subcutaneous 12 microgram dose of HemaMax<br>* Other names: rHuIL-12, NM-IL-12;|
| Placebo Comparator: Placebo<br>Single subcutaneous dose | Drug: Placebo<br>* single subcutaneous dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of HemaMax in healthy subjects. | Number of subjects with adverse events as a measure of safety and tolerability | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects | To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax. | 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