A Phase 2 interventional study of placebo-Q2W and HMI-115-120mg-Q4W in Androgenetic Alopecia, sponsored by Hope Medicine (Nanjing) Co., Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Hope Medicine (Nanjing) Co., Ltd · Phase 2, Interventional, and Treatment
To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 192 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Hope Medicine (Nanjing) Co., Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject has any of the following conditions within 6 weeks prior to Screening:
placebo, 0mg/vials
Drug: placebo-Q2W
HMI-115, 60mg/vials
Drug: HMI-115-120mg-Q4W
HMI-115, 60mg/vials
Drug: HMI-115-240mg-Q4W
HMI-115, 60mg/vials
Drug: HMI-115, 240mg-Q2W
placebo, 0mg，SC，Q2W，12 cycles
HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)
HMI-115, 240mg，SC，Q2W，12 cycles
The Rate of Target Arean Hair Count (TAHC)
The mean change in TAHC of non-vellus from baseline
Time frame: 24 Weeks
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 36 Weeks
Pulse change from baseline
Descriptive statistics summarizing changes in pulse will be compared between baseline levels and each predetermined time point.
Time frame: 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.
Time frame: 36 Weeks
Respiratory rate
Descriptive statistics summarizing changes in respiratory rate will be compared between baseline levels and each predetermined time point.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 Weeks
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Hope Medicine (Nanjing) Co., Ltd