Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT01647893
Status:
UNKNOWN
Last Update Posted:
2012-07-24
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Single Dose Escalation Study of CTB-001
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C074619', 'term': 'bivalirudin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-19', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 7 hours', 'description': 'Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males aged 20 to 40 years at screening.\n* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.\n\nExclusion Criteria:\n\n* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.\n* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.\n* History of known hypersensitivity to drugs including CTB-001'}, 'identificationModule': {'nctId': 'NCT01647893', 'briefTitle': 'Phase 1 Single Dose Escalation Study of CTB-001', 'organization': {'class': 'INDUSTRY', 'fullName': 'HLB Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'CTB-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose', 'interventionNames': ['Drug: CTB-001']}, {'type': 'EXPERIMENTAL', 'label': 'CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose', 'interventionNames': ['Drug: CTB-001']}, {'type': 'EXPERIMENTAL', 'label': 'CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose', 'interventionNames': ['Drug: CTB-001']}, {'type': 'EXPERIMENTAL', 'label': 'CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation', 'interventionNames': ['Drug: CTB-001']}], 'interventions': [{'name': 'CTB-001', 'type': 'DRUG', 'description': 'IV bolus or IV infusion', 'armGroupLabels': ['CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose', 'CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation', 'CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose', 'CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyun-Seop Bae, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'ksbae@amc.seoul.kr', 'phone': '82-2-3010-4611'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyun-Seop Bae, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HLB Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}