Madison, Wisconsin 53704

  • Hematopoietic Syndrome Due to Acute Radiation Syndrome

Purpose:

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


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


NCT ID:

NCT01742221


Primary Contact:

Principal Investigator
Nicholas Siebers, MD
Covance Clinical Research Unit


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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