Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 6:11 PM
Study NCT ID:
NCT01363934
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594298', 'term': 'GC1113'}, {'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/ Tolerability Evaluation', 'timeFrame': 'Up to 29 days after investigational product administration', 'description': 'Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)'}], 'secondaryOutcomes': [{'measure': 'AUClast of GC1113, Cmax of GC1113', 'timeFrame': 'Up to 29 days after investigational product administration', 'description': 'Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents'}, {'measure': 'Immunogenicity of GC1113', 'timeFrame': 'Up to 29 days after investigational product administration', 'description': 'Antibody (GC1113) test'}, {'measure': 'To compare safety and Pharmacokinetics/Pharmacodynamics with active control', 'timeFrame': 'Up to 29 days after investigational product administration', 'description': 'Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erythropoietin', 'EPO-hFC'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Adult male subjects between 20 to 55 years of age\n* 60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27\n* 12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection\n* WBC ≥ 3.0Ⅹ10\\^9/L, platelet ≥ 140Ⅹ10\\^9/L within the 28 days prior to IP injection\n\nExclusion Criteria:\n\n* Allergic to IP ingredients\n* History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease\n* Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation\n* History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation\n* Epilepsy within the 6 months prior to IP injection\n* Positivity for HIV antibody, HBsAg, HCV antibody test\n* Spleen length \\> 16㎝'}, 'identificationModule': {'nctId': 'NCT01363934', 'briefTitle': 'To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'A Dose-Block Randomized, Double-blind Placebo Controlled, Open-label Active Controlled, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 After Single Intravenous/Subcutaneous Administration in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'GC1113_P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously', 'interventionNames': ['Drug: GC1113']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa 30ug/kg by IV', 'description': 'Darbepoetin alfa 30ug/kg once intravenously', 'interventionNames': ['Drug: Darbepoetin alfa']}, {'type': 'EXPERIMENTAL', 'label': 'Group H', 'description': 'GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group J', 'description': 'GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously', 'interventionNames': ['Drug: GC1113']}, {'type': 'EXPERIMENTAL', 'label': 'Group K', 'description': 'GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously', 'interventionNames': ['Drug: GC1113']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa 30ug/kg by SC', 'description': 'Darbepoetin alfa 30ug/kg once subcutaneously', 'interventionNames': ['Drug: Darbepoetin alfa']}], 'interventions': [{'name': 'GC1113', 'type': 'DRUG', 'description': 'Each Group volunteers (n=10) will be administered GC1113 0.3ug/kg to 5ug/kg or Placebo (GC1113:placebo=8:2) once intravenously.\n\nEach Group volunteers (n=10) will be administered GC1113 1ug/kg to 8ug/kg or Placebo (GC1113:placebo=8:2) once subcutaneously.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group H', 'Group I', 'Group J', 'Group K']}, {'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': 'Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.', 'armGroupLabels': ['Darbepoetin alfa 30ug/kg by IV', 'Darbepoetin alfa 30ug/kg by SC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyung-Sang Yu, MD., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Symyoo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}