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

Primary Purpose

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HemaMax

Placebo

About this trial

This is an interventional treatment trial for Hematopoietic Syndrome Due to Acute Radiation Syndrome focused on measuring HemaMax, NM-IL-12, HSARS, Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Covance Clinical Research Unit
Covance Clinical Research Unit
Covance Clinical Research Unit
Covance Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HemaMax

Placebo

Arm Description

Single subcutaneous 12 microgram dose of HemaMax

Single subcutaneous dose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)

PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure

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

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

Anti-drug antibodies as a measure of immunogenicity

Full Information

NCT ID

NCT02343133

First Posted

January 13, 2015

Last Updated

November 14, 2018

Sponsor

Neumedicines Inc.

Collaborators

Department of Health and Human Services

1. Study Identification

Unique Protocol Identification Number

NCT02343133

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neumedicines Inc.

Collaborators

Department of Health and Human Services

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematopoietic Syndrome Due to Acute Radiation Syndrome

Keywords

HemaMax, NM-IL-12, HSARS, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HemaMax

Arm Type

Experimental

Arm Description

Single subcutaneous 12 microgram dose of HemaMax

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single subcutaneous dose

Intervention Type

Biological

Intervention Name(s)

HemaMax

Other Intervention Name(s)

rHuIL-12, NM-IL-12

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)

Description

Number of subjects with adverse events as a measure of safety and tolerability

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)

Description

PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure

Time Frame

3 months

Title

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

Description

IFN-g and CXCL-10 induction as a measure of pharmacodynamic response

Time Frame

3 months

Title

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

Description

Anti-drug antibodies as a measure of immunogenicity

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Siebers, MD

Organizational Affiliation

Covance Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Covance Clinical Research Unit

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Covance Clinical Research Unit

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47710

Country

United States

Facility Name

Covance Clinical Research Unit

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

Facility Name

Covance Clinical Research Unit

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24725395

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.

Results Reference

background

PubMed Identifier

24852354

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.

Results Reference

background

PubMed Identifier

26207689

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

Results Reference

background

PubMed Identifier

24708888

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.

Results Reference

background

PubMed Identifier

22383962

Citation

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.

Results Reference

background

Links:

URL

http://www.ehoonline.org/content/3/1/11

Description

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

Learn more about this trial

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

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