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

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.

Inclusion Criteria:

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

1. 18 to 45 years of age

2. Body mass index (BMI) > 19 and < 0 kg/m2

3. Normal ECG, vital signs and laboratory test results

4. Use of effective birth control method and abstinence from sex

5. Negative pregnancy test and drug screen

Exclusion Criteria:

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

1. History of clinically significant renal, hepatic pulmonary, cardiovascular,
cerebrovascular, gastrointestinal, metabolic, hematological, endocrine,
urological, immunological, neurologic or psychiatric disorders or connective
tissue disease

2. Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen
(HBsAg) or Hepatitis C antibody, tuberculosis (TB)

3. Current drug or alcohol addiction

4. History of clinically significant allergy of any kind

5. Prior use of IL-12 or HemaMax

6. Use of any approved or investigational biologic agents or vaccinations of any
kind in last 3 months