Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 4:44 AM
Study NCT ID:
NCT07364851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'up to 48 hour'}, {'measure': 'AUC0-t', 'timeFrame': 'up to 48 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Volunteer']}, 'descriptionModule': {'briefSummary': 'Safety and pharmacokinetic characteristics evaluation of DW4421-T1 and DW4421S-T1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult aged 19 to 50 (inclusive) years\n* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)\n\nExclusion Criteria:\n\n* clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history'}, 'identificationModule': {'nctId': 'NCT07364851', 'briefTitle': 'A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DW4421-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'cross-over', 'interventionNames': ['Drug: DW4421-T1', 'Drug: DW4421S-T1']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Cross-over', 'interventionNames': ['Drug: DW4421-T1', 'Drug: DW4421S-T1']}], 'interventions': [{'name': 'DW4421-T1', 'type': 'DRUG', 'description': 'DW4421-T1 or DW4421S-T1', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'DW4421S-T1', 'type': 'DRUG', 'description': 'DW4421-T1 or DW4421S-T1', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}