To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HMI-115 240mg
|
Drug: HMI-115
Once Every 2 weeks, subcutaneously injection
|
Outcome Measures
Primary Outcome Measures
- TAHC(target area hair count) of non-vellus [From baseline to Week 24]
Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.
Secondary Outcome Measures
- TAHC of non-vellus [From baseline to Week 6, 12, 18, and 36]
Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
- TAHW(target area hair width) of non-vellus hair [From baseline to Week 6, 12, 18, 24, and 36]
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.
- Investigator Global Assessment (IGA) [Week 6, 12, 18, 24, and 36]
IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
- Subject self-Assessment (SSA) [Week 6, 12, 18, 24, and 36]
SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
- Hair growth questionnaire assessment (HGQA) [Week 6, 12, 18, 24, and 36]
HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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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 Criteria:
-
Subject with clinical diagnosis of non-AGA
-
Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology | Melbourne E. | Victoria | Australia |
Sponsors and Collaborators
- Hope Medicine (Nanjing) Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMI-115102