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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

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