Phase
Condition
Scalp Disorders
Male Pattern Baldness
Hair Loss
Treatment
HMI-115-120mg-Q4W
placebo-Q2W
HMI-115, 240mg-Q2W
Clinical Study ID
Ages 18-65 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have given written informed consent before any study-related activities arecarried 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 signinginformed consent.
Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamiltonscales III vertex, IV and V .
Be willing and able to comply with all study assessments and adhere to the protocolschedule and restrictions, including having a small circle about 1 cm2 of hairclipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of targetarea.
Subjects who are willing to keep the same hair color, refrain from hair weaving, andhair growth therapy and supplement (except for protocol specified IMP) during thestudy.
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 islonger.
Exclusion
Exclusion Criteria:
Subject with history of scalp radiation or surgery which could interfere studyassessment (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 (systolicblood 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 IIIor IV.
Subject has high fever, major surgery, or ten percent or more weight decrease withinthree 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.
Study Design
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100035
ChinaActive - Recruiting
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