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

Hematopoietic Syndrome Due to Acute Radiation Syndrome Clinical Trial

Official title:

A Phase 2 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: NCT02343133
• Other study ID #: 2014-003
• Secondary ID: #HHSO10020110003
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: April 2016

Study information

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

Clinical Trial Summary

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.

Description:

This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

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)

• 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

Related Conditions & MeSH terms

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

Intervention

Biological:
• HemaMax

Drug:
• Placebo

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Dallas	Texas
United States	Covance Clinical Research Unit	Daytona Beach	Florida
United States	Covance Clinical Research Unit	Evansville	Indiana
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 (5)

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

Gokhale MS, Vainstein V, Tom J, Thomas S, Lawrence CE, Gluzman-Poltorak Z, Siebers N, Basile LA. Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects. Exp Hematol Oncol. 2014 Apr 11;3(1):11. doi: 10.1186/2162-3619-3-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)	Number of subjects with adverse events as a measure of safety and tolerability	3 months
Secondary	Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)	PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure	3 months
Secondary	Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)	IFN-g and CXCL-10 induction as a measure of pharmacodynamic response	3 months
Secondary	Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)	Anti-drug antibodies as a measure of immunogenicity	3 months

External Links

•   Single Low-dose rHuIL-12 Safely Triggers Multilineage Hematopoietic and Immune-mediated Effects.