Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
Primary Purpose
Hematopoietic Syndrome Due to Acute Radiation Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HemaMax
Placebo
Sponsored by
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
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
Sites / Locations
- 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
To determine the safety and tolerability of HemaMax in healthy subjects.
Number of subjects with adverse events as a measure of safety and tolerability
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01742221
First Posted
August 6, 2012
Last Updated
November 14, 2018
Sponsor
Neumedicines Inc.
Collaborators
Department of Health and Human Services
1. Study Identification
Unique Protocol Identification Number
NCT01742221
Brief Title
Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (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
This trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of HemaMax in healthy male and female volunteers.
Detailed 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.
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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (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 Description
single subcutaneous 12 microgram dose of HemaMax
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single subcutaneous dose
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of HemaMax in healthy subjects.
Description
Number of subjects with adverse events as a measure of safety and tolerability
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To characterize the pharmacokinetics, pharmacodynamics and immunogenicity of HemaMax in healthy subjects
Description
To evaluate PK parameters AUC, Cmax, Tmax, t ½, Vz/F, and CL/F for HemaMax. To evaluate biological response parameters following HemaMax.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Siebers, MD
Organizational Affiliation
Covance Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
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
No
Citations:
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
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
derived
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Safety and Tolerability of HemaMax™ (rHuIL-12) as Radiation Countermeasure
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