Trial | NCT01742221  Report issue

Title

Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
A Phase 1b, Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.
A randomized, placebo-controlled, double-blind study of HemaMax to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of a single 12 μg subcutaneous dose of HemaMax on 60 healthy subjects for 28 days after HemaMax administration.
Study Started
Aug 31
2012
Primary Completion
Nov 30
2012
Study Completion
Dec 31
2012
Last Update
Nov 16
2018

Biological HemaMax

single subcutaneous 12 microgram dose of HemaMax

  • Other names: rHuIL-12, NM-IL-12

Drug Placebo

single subcutaneous dose

HemaMax Experimental

Single subcutaneous 12 microgram dose of HemaMax

Placebo Placebo Comparator

Single subcutaneous dose

Criteria 

Inclusion Criteria:

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

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)
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
No Results Posted