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

Hematopoietic Syndrome Due to Acute Radiation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742221
• Other study ID #: 2012-002
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2018
• Source: Neumedicines Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Radiation Syndrome
• Hematopoietic Syndrome Due to Acute Radiation Syndrome
• Radiation Injuries

Intervention

Biological:
• HemaMax
single subcutaneous 12 microgram dose of HemaMax

Drug:
• Placebo
single subcutaneous dose

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

Basile LA, Ellefson D, Gluzman-Poltorak Z, Junes-Gill K, Mar V, Mendonca S, Miller JD, Tom J, Trinh A, Gallaher TK. HemaMax™, a recombinant human interleukin-12, is a potent mitigator of acute radiation injury in mice and non-human primates. PLoS One. 2012;7(2):e30434. doi: 10.1371/journal.pone.0030434. Epub 2012 Feb 24. — View Citation

Gluzman-Poltorak Z, Mendonca SR, Vainstein V, Kha H, Basile LA. Randomized comparison of single dose of recombinant human IL-12 versus placebo for restoration of hematopoiesis and improved survival in rhesus monkeys exposed to lethal radiation. J Hematol Oncol. 2014 Apr 6;7:31. doi: 10.1186/1756-8722-7-31. — View Citation

Gluzman-Poltorak Z, Vainstein V, Basile LA. Association of Hematological Nadirs and Survival in a Nonhuman Primate Model of Hematopoietic Syndrome of Acute Radiation Syndrome. Radiat Res. 2015 Aug;184(2):226-30. Epub 2015 Jul 24. — View Citation

Gluzman-Poltorak Z, Vainstein V, Basile LA. Recombinant interleukin-12, but not granulocyte-colony stimulating factor, improves survival in lethally irradiated nonhuman primates in the absence of supportive care: evidence for the development of a frontline radiation medical countermeasure. Am J Hematol. 2014 Sep;89(9):868-73. doi: 10.1002/ajh.23770. Epub 2014 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of HemaMax in healthy subjects.	Number of subjects with adverse events as a measure of safety and tolerability	3 months
Secondary	To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects	To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.	3 months