Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT04159961
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2019-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h', 'description': 'Maximum concentration of DWJ211'}, {'measure': 'Tmax', 'timeFrame': '0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h', 'description': 'Time of maximum concentration'}, {'measure': 'AUCt', 'timeFrame': '0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h', 'description': 'Area under the drug concentration-time curve'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult aged between 19 and 65 at screening\n* Those whose BMI is less than 40kg/m2\n* Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)\n* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc\n\nExclusion Criteria:\n\n* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history\n* History of any intervention to treat Submental fat or abdominal fat\n* History or current symptoms of dysphagia\n* History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment'}, 'identificationModule': {'nctId': 'NCT04159961', 'briefTitle': 'Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ211101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GroupA', 'description': 'Inject the Drug into submental fat and abdominal fat via subcutaneous', 'interventionNames': ['Drug: DWJ211']}, {'type': 'EXPERIMENTAL', 'label': 'GroupB', 'description': 'Inject the Drug into submental fat and abdominal fat via subcutaneous', 'interventionNames': ['Drug: DWJ211']}, {'type': 'EXPERIMENTAL', 'label': 'GroupC', 'description': 'Inject the Drug into submental fat and abdominal fat via subcutaneous', 'interventionNames': ['Drug: DWJ211']}], 'interventions': [{'name': 'DWJ211', 'type': 'DRUG', 'description': 'Inject the Drug into submental fat and abdominal fat via subcutaneous', 'armGroupLabels': ['GroupA', 'GroupB', 'GroupC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}