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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hematopoietic Syndrome Due to Acute Radiation Syndrome

In brief

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.

Key facts

Study ID

NCT02343133

Run by

Neumedicines Inc.

People needed

200

Starts

2015-01-01

Expected to finish

2016-04-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Research Unit — Daytona Beach, Florida, United States
• Covance Clinical Research Unit — Evansville, Indiana, United States
• Covance Clinical Research Unit — Dallas, Texas, United States
• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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