Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-05 @ 9:38 PM
Study NCT ID:
NCT05324293
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TAHC(target area hair count) of non-vellus', 'timeFrame': 'From baseline to Week 24', 'description': 'Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.'}], 'secondaryOutcomes': [{'measure': 'TAHC of non-vellus', 'timeFrame': 'From baseline to Week 6, 12, 18, and 36', 'description': 'Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.'}, {'measure': 'TAHW(target area hair width) of non-vellus hair', 'timeFrame': 'From baseline to Week 6, 12, 18, 24, and 36', 'description': 'Change in target area hair width (TAHW) of non-vellus hair from baseline to Week 6, 12, 18, 24, and 36 in male and female, respectively.'}, {'measure': 'Investigator Global Assessment (IGA)', 'timeFrame': 'Week 6, 12, 18, 24, and 36', 'description': 'IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.'}, {'measure': 'Subject self-Assessment (SSA)', 'timeFrame': 'Week 6, 12, 18, 24, and 36', 'description': 'SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.'}, {'measure': 'Hair growth questionnaire assessment (HGQA)', 'timeFrame': 'Week 6, 12, 18, 24, and 36', 'description': 'HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.\n2. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.\n3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.\n\nExclusion Criteria:\n\n1. Subject with clinical diagnosis of non-AGA\n2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment\n3. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening\n4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction\n5. Subject has clinically significantly abnormal laboratory tests at Screening\n6. Known hypersensitivity to any of the IMP ingredients\n7. Any other conditions in the investigator's opinion that prevent the subject from participating"}, 'identificationModule': {'nctId': 'NCT05324293', 'briefTitle': 'To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hope Medicine (Nanjing) Co., Ltd'}, 'officialTitle': 'An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 Over a 24-Week Treatment Period', 'orgStudyIdInfo': {'id': 'HMI-115102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HMI-115 240mg', 'interventionNames': ['Drug: HMI-115']}], 'interventions': [{'name': 'HMI-115', 'type': 'DRUG', 'description': 'Once Every 2 weeks, subcutaneously injection', 'armGroupLabels': ['HMI-115 240mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne E.', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hope Medicine (Nanjing) Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}