To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period
NCT ID: NCT05324293
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2022-05-11
2023-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HMI-115 240mg
HMI-115
Once Every 2 weeks, subcutaneously injection
Interventions
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HMI-115
Once Every 2 weeks, subcutaneously injection
Eligibility Criteria
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Inclusion Criteria
2. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.
Exclusion Criteria
2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
3. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP ingredients
7. Any other conditions in the investigator's opinion that prevent the subject from participating
18 Years
65 Years
ALL
No
Sponsors
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Hope Medicine (Nanjing) Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Melbourne E., Victoria, Australia
Countries
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Other Identifiers
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HMI-115102
Identifier Type: -
Identifier Source: org_study_id
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