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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hematopoietic Syndrome Due to Acute Radiation Syndrome

In brief

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

Key facts

Study ID

NCT01742221

Run by

Neumedicines Inc.

People needed

60

Starts

2012-08-01

Expected to finish

2012-12-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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)
• 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

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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