A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia

Study Overview
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Brief Summary
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To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks

Official Title
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A Randomized, Multicenter, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy in Male 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: placebo-Q2W
* Drug: HMI-115-120mg-Q4W
* Drug: HMI-115-240mg-Q4W
* Drug: HMI-115, 240mg-Q2W


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 subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V . Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area. Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study. Subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of IMP or complete whole study period whichever is longer. Exclusion Criteria: Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery). Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc. Subject with history of hair weaves within 3 months prior screening. Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism. Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg). Subject has any of the following conditions within 6 weeks prior to Screening: Myocardial infarction, stroke, unstable angina, or transient ischemic attack. Heart failure with classified as being in New York Heart Association Class III or IV. Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening. Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp). Subject plans to schedule elective surgery during the study.

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

Sexes Eligible for Study
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Male

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo-Q2W<br>placebo, 0mg/vials | Drug: placebo-Q2W<br>* placebo, 0mg，SC，Q2W，12 cycles<br>|
| Active Comparator: HMI-115-120mg-Q4W<br>HMI-115, 60mg/vials | Drug: HMI-115-120mg-Q4W<br>* HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)<br>|
| Active Comparator: HMI-115-240mg-Q4W<br>HMI-115, 60mg/vials | Drug: HMI-115-240mg-Q4W<br>* HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)<br>|
| Active Comparator: HMI-115-240mg-Q2W<br>HMI-115, 60mg/vials | Drug: HMI-115, 240mg-Q2W<br>* HMI-115, 240mg，SC，Q2W，12 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Target Arean Hair Count (TAHC) | The mean change in TAHC of non-vellus from baseline | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA) | To assess the hair growth by 7-question questionnaire and summary the number and percentage of subjects in each category for each HGQA question. | 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks | 
| Target Area Hair Count (TAHC) change from baseline | The mean change in TAHC of non-vellus from Baseline | 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks | 
| Rate of Target Area Hair Width (TAHW) | The mean change in TAHW of non-vellus from baseline | 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks | 
| Investigator Global Assessment (IGA) | Summary of subject number and percentage in each IGA category | 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks | 
| Subject Self-Assessment (SSA) | Summary of subject number and percentage in each SSA category | 6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks | 
| Norwood-Hamilton Grade change from baseline | Summary of subject number and percentage in each grade of Norwood-Hamilton Scale | 12 weeks, 24 weeks, and 36 weeks | 
| Frequencies and percentages of Adverse event (AE) | Frequency and percentages of subjects with treatment-emergent AE (TEAE) will be calculated and TEAE will be summarized by systematic organ classification (SOC), preferred term (PT), relationship to study treatment, maximum severity, whether resulting in death, whether resulting in study treatment discontinuation, belong to serious AE (SAE) or not, belong to events of special interest (AESI) or not. | 36Weeks | 
| Blood Pressure change from baseline | Descriptive statistics summarizing changes in blood pressure (systolic and diastolic) will be compared between baseline levels and each predetermined time point. | 36 Weeks | 
| Pulse change from baseline | Descriptive statistics summarizing changes in pulse will be compared between baseline levels and each predetermined time point. | 36 Weeks | 
| Body temperature change from baseline | Descriptive statistics summarizing changes in body temperature will be compared between baseline levels and each predetermined time point. | 36 Weeks | 
| Respiratory rate | Descriptive statistics summarizing changes in respiratory rate will be compared between baseline levels and each predetermined time point. | 36 Weeks | 
| Complete or brief physical examination, at a minimum of General appearance, HEENT (head, eyes, ears, nose, throat), Neck, Lung/pulmonary, Chest, Neurological or not, Extremities,ect.to assess the physical health state. | Physical examination findings by body system will be summarized, presented with frequency counts and percentages. A complete or brief physical examination will be performed at Visit 1, Visit 2, End of Treatment Visit and Follow-up Visit. Height (cm) and weight (kg) will be measured and body mass index will be calculated and recorded at specified period. | 36 Weeks | 
| Concomitant Medication | Concomitant medication usage will be summarized by the number and proportion of subjects and classified by the World Health Organization Drug Dictionary (WHO DD) based on Anatomical Therapeutic Chemical Classification System (ATC) code level 3. | 36 Weeks | 
| Change in twelve-lead electrocardiogram parameters | Change in electrocardiogram parameters including heart rate (HR), QRS, RR, PR, and QT interval (QTcF and QTcB) relative to baseline will be summarized descriptively by visits and groups. The within-group changes from baseline to each visit will be summarized and will be compared with a paired t-test for continuous measurements. Subject number and percentage with other clinically significant electrocardiogram findings in each visit will be summarized by groups. A general assessment of the 12-lead electrocardiogram will be presented as normal, abnormal clinical significance, or abnormal no clinical significance. | 36 Weeks | 
| Clinical laboratory tests of hematology | Descriptive statistics summarizing changes in results of clinical laboratory tests of hematology from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided. | 36 Weeks | 
| Clinical laboratory tests of coagulation | Descriptive statistics summarizing changes in results of clinical laboratory tests of coagulation from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided. | 36 Weeks | 
| Clinical laboratory tests of clinical chemistry | Descriptive statistics summarizing changes in results of clinical laboratory tests of clinical chemistry from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided. | 36 Weeks | 
| Clinical laboratory tests of urinalysis | Descriptive statistics summarizing changes in results of clinical laboratory tests of urinalysis from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided. | 36 Weeks | 
| Clinical laboratory tests of hormones | Descriptive statistics summarizing changes in results of clinical laboratory tests of hormones from baseline levels at each predetermined time point. Shift tables for changes from baseline according to the normal minimum and maximum will be provided. | 36 Weeks |