Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 5:34 AM
Study NCT ID:
NCT06974292
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative excretion rate of radioactivity in urine', 'timeFrame': 'from 0 hour to 216 hours after administration'}, {'measure': 'Cumulative excretion rate of radioactivity in feces', 'timeFrame': 'from 0 hour to 216 hours after administration'}, {'measure': 'Total radioactivity', 'timeFrame': 'from 0 hour to 216 hours after administration'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From signing the ICF until 10 days after the dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the mass balance and biotransformation after single-dose of \\[14C\\]VC005 orally in Chinese healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A healthy male adult.\n* Age is between 18 and 45, inclusive.\n* Weight ≥ 50 kg and Body mass index is between 19 and 26, inclusive.\n* Voluntarily to provide informed consent form.\n* Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.\n\nExclusion Criteria:\n\n* Any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest X-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on.\n* Tested positive for any one of the following: HBsAg/HBeAg, Anti-HCV IgG, HIV-Ag/Ab or treponema pallidum antibody (Syphilis) .\n* Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam.\n* Volunteers are not suitable for this clinical trial, in the opinions of investigators.'}, 'identificationModule': {'nctId': 'NCT06974292', 'briefTitle': 'The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu vcare pharmaceutical technology co., LTD'}, 'officialTitle': 'The Mass Balance and Biotransformation Study of [14C]VC005 in Chinese Healthy Adult Male Volunteers', 'orgStudyIdInfo': {'id': 'VC005-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]VC005', 'interventionNames': ['Drug: [14C]VC005']}], 'interventions': [{'name': '[14C]VC005', 'type': 'DRUG', 'description': 'Take a suspension of 50 mg VC005 ,containing about 120 μCi \\[14C\\]VC005, in fasting within 5 minutes', 'armGroupLabels': ['[14C]VC005']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Liyan Miao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Suzhou Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu vcare pharmaceutical technology co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}