To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: HMI-115


Participation Criteria
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Eligibility Criteria
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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. 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMI-115 240mg<br> | Drug: HMI-115<br>* Once Every 2 weeks, subcutaneously injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAHC(target area hair count) of non-vellus | Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively. | From baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAHC of non-vellus | Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively. | From baseline to Week 6, 12, 18, and 36 | 
| TAHW(target area hair width) of non-vellus hair | 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. | From baseline to Week 6, 12, 18, 24, and 36 | 
| Investigator Global Assessment (IGA) | IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively. | Week 6, 12, 18, 24, and 36 | 
| Subject self-Assessment (SSA) | SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively. | Week 6, 12, 18, 24, and 36 | 
| Hair growth questionnaire assessment (HGQA) | HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively. | Week 6, 12, 18, 24, and 36 |