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

NCT02343133 | Completed Phase 2 DMC

• 2 other identifiers: 2014-003#HHSO100201100037C
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Keywords

HemaMax, NM-IL-12, HSARS, Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)

  3 months

• Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)

  3 months

• Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)

  3 months

Study Arms (2)

HemaMax

EXPERIMENTAL

Single subcutaneous 12 microgram dose of HemaMax

Biological: HemaMax

Placebo

PLACEBO COMPARATOR

Single subcutaneous dose

Drug: Placebo

Interventions

HemaMax BIOLOGICAL

Also known as: rHuIL-12, NM-IL-12

HemaMax

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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)
• 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

Sponsors & Collaborators

• Neumedicines Inc.: lead
• Department of Health and Human Services: collaborator

Study Sites (4)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Unit

Evansville, Indiana, 47710, United States

Location

Covance Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Publications (5)

• 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.

  PMID: 24725395 BACKGROUND

• 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.

  PMID: 24852354 BACKGROUND

• 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. doi: 10.1667/rr13962.1. Epub 2015 Jul 24.

  PMID: 26207689 BACKGROUND

• 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.

  PMID: 24708888 BACKGROUND

• 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.

  PMID: 22383962 BACKGROUND

Related Links

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

MeSH Terms

Interventions

Interleukin-12 Subunit p35

Intervention Hierarchy (Ancestors)

Interleukin-12; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Nicholas Siebers, MD

  Covance Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 21, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)