Status:
COMPLETED
A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia
Lead Sponsor:
Hope Medicine (Nanjing) Co., Ltd
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks
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 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
- 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.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2024
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06118866
Start Date
September 11 2023
End Date
November 28 2024
Last Update
June 4 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100035