Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:06 AM
Study NCT ID:
NCT06009094
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax）', 'timeFrame': 'Day2,Day 4,Day17,Day31'}], 'secondaryOutcomes': [{'measure': 'Changes in EASI（Eczema area and severity index） from baseline', 'timeFrame': 'Week 2,Week 4'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nhealthy subject's study:\n\n1. Healthy male or female subjects, aged 18-45 years (including critical values);\n2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;\n3. All women and men with fertility potential must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;\n4. Voluntarily participate in the experiment and sign an informed consent form;\n5. Subjects who are able to communicate well with the researcher and are willing and able to comply with all planned visits, treatment plans, laboratory tests, and other research procedures\n\npatient's study:\n\n1. When informed consent is given, the age range is between 18 and 75 years (including the boundary value), regardless of gender;\n2. Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;\n3. Before administration, the diagnosis of mild to moderate atopic dermatitis should be met:\n\n Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total area of skin lesions 3% ≤ body surface area≤ 20%\n4. Voluntarily sign an informed consent form (with a date), indicating that the subject has been informed of all relevant parts of the study;\n5. All women and men with the possibility of childbirth must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;\n6. Subjects who are willing and able to comply with planned visits and treatment plans, laboratory tests, and other research procedures\n\nExclusion Criteria:\n\nhealthy subject's study:\n\n1. Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;\n2. Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;\n3. Screening for individuals who have undergone any surgery within the previous 6 months;\n4. Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);\n5. Female subjects of childbearing age had unprotected sexual intercourse with their opposite sex partner within 14 days prior to screening;\n6. Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;\n7. Pregnant and lactating women;\n8. Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;\n9. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;\n10. Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;\n11. Other situations where the researcher determines that it is not suitable to participate in the experiment.\n\npatient's study:\n\n1. Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;\n2. Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;\n3. Screening for individuals who have undergone any surgery within the previous 6 months;\n4. Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);\n5. Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;\n6. Pregnant and lactating women;\n7. Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;\n8. Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;\n9. Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;\n10. Other situations where the researcher determines that it is not suitable to participate in the experiment."}, 'identificationModule': {'nctId': 'NCT06009094', 'briefTitle': 'Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu vcare pharmaceutical technology co., LTD'}, 'officialTitle': 'Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'YQ-M-23-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VC005 Low Dose groups', 'interventionNames': ['Drug: VC005']}, {'type': 'EXPERIMENTAL', 'label': 'VC005 median-A Dose groups', 'interventionNames': ['Drug: VC005']}, {'type': 'EXPERIMENTAL', 'label': 'VC005 median-B Dose groups', 'interventionNames': ['Drug: VC005']}, {'type': 'EXPERIMENTAL', 'label': 'VC005 high Dose groups', 'interventionNames': ['Drug: VC005']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'VC005 Placebo groups', 'interventionNames': ['Drug: VC005 Placebo']}], 'interventions': [{'name': 'VC005', 'type': 'DRUG', 'description': 'VC005 group with Local topical application', 'armGroupLabels': ['VC005 Low Dose groups', 'VC005 high Dose groups', 'VC005 median-A Dose groups', 'VC005 median-B Dose groups']}, {'name': 'VC005 Placebo', 'type': 'DRUG', 'description': 'VC005 Placebo group with Local topical application', 'armGroupLabels': ['VC005 Placebo groups']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences Hospital of Skin Disease', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Qianjin Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences Hospital of Skin Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu vcare pharmaceutical technology co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}