Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-10 @ 11:45 PM
Study NCT ID:
NCT02343133
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053765', 'term': 'Interleukin-12 Subunit p35'}], 'ancestors': [{'id': 'D018664', 'term': 'Interleukin-12'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)', 'timeFrame': '3 months', 'description': 'Number of subjects with adverse events as a measure of safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)', 'timeFrame': '3 months', 'description': 'PK parameters such as AUC, Cmax and Tmax as measures of pharmacokinetic exposure'}, {'measure': 'Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)', 'timeFrame': '3 months', 'description': 'IFN-g and CXCL-10 induction as a measure of pharmacodynamic response'}, {'measure': 'Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)', 'timeFrame': '3 months', 'description': 'Anti-drug antibodies as a measure of immunogenicity'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HemaMax, NM-IL-12, HSARS, Safety'], 'conditions': ['Hematopoietic Syndrome Due to Acute Radiation Syndrome']}, 'referencesModule': {'references': [{'pmid': '24725395', 'type': 'BACKGROUND', '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.'}, {'pmid': '24852354', 'type': 'BACKGROUND', '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.'}, {'pmid': '26207689', 'type': 'BACKGROUND', '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.'}, {'pmid': '24708888', 'type': 'BACKGROUND', '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.'}, {'pmid': '22383962', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ehoonline.org/content/3/1/11', 'label': 'Single Low-dose rHuIL-12 Safely Triggers Multilineage Hematopoietic and Immune-mediated Effects.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and Female healthy subjects who have signed the informed consent form must meet all of the following criteria\n\n* ≥18 to ≤75 years of age\n* Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2\n* Normal ECG, vital signs and laboratory test results\n* Use of effective birth control method and abstinence from sex\n* Negative pregnancy test and drug screen\n\nExclusion Criteria:\n\nSubjects with any of the following characteristics will be considered ineligible:\n\n* History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease\n* Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB)\n* Drug or alcohol addiction\n* History of clinically significant allergy of any kind\n* Prior use of IL-12 or HemaMax\n* Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months'}, 'identificationModule': {'nctId': 'NCT02343133', 'briefTitle': 'Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neumedicines Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2014-003'}, 'secondaryIdInfos': [{'id': '#HHSO100201100037C', 'type': 'OTHER_GRANT', 'domain': 'BARDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HemaMax', 'description': 'Single subcutaneous 12 microgram dose of HemaMax', 'interventionNames': ['Biological: HemaMax']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single subcutaneous dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HemaMax', 'type': 'BIOLOGICAL', 'otherNames': ['rHuIL-12, NM-IL-12'], 'armGroupLabels': ['HemaMax']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Nicholas Siebers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Covance Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neumedicines Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Department of Health and Human Services', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}