Status:
COMPLETED
To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period
Lead Sponsor:
Hope Medicine (Nanjing) Co., Ltd
Conditions:
Androgenetic Alopecia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
- Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
- 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
- Subject with clinical diagnosis of non-AGA
- Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
- Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
- Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
- Subject has clinically significantly abnormal laboratory tests at Screening
- Known hypersensitivity to any of the IMP ingredients
- Any other conditions in the investigator's opinion that prevent the subject from participating
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05324293
Start Date
May 11 2022
End Date
September 11 2023
Last Update
September 19 2024
Active Locations (1)
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1
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Melbourne E., Victoria, Australia