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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neumedicines Inc.
• Collaborator: Department of Health and Human Services

Criteria

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