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

Launched by HOPE MEDICINE (NANJING) CO., LTD · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HMI-115 for men with a condition known as androgenetic alopecia, which is a common form of hair loss. The goal is to see if HMI-115 is effective in treating this condition compared to a placebo (a treatment that does not contain any active medication) over a period of 24 weeks. The trial is currently looking for male participants between the ages of 18 and 65 who have a specific level of hair loss as defined by a scale called the Norwood-Hamilton scale. To join, participants must also be willing to follow certain guidelines, such as not using other hair treatments or changing their hair color during the study.

If you decide to participate, you can expect to undergo regular assessments and to have a small area of your scalp prepared for the study, which may involve clipping your hair and applying a small tattoo to help monitor the effects of the treatment. It’s important to note that some individuals will not qualify for the trial, including those with certain medical histories, recent surgeries, or specific health conditions. This study aims to provide valuable information about the safety and effectiveness of HMI-115 for treating hair loss in men.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
• • 3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
• • 4. 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.
• • 5. 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.
• • 6. 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:
• • 1. Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
• • 2. Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
• • 3. Subject with history of hair weaves within 3 months prior screening.
• • 4. Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
• • 5. Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure \[SBP\] \> 159 mmHg, diastolic blood pressure \[DBP\] \> 99 mmHg).
• 6. Subject has any of the following conditions within 6 weeks prior to Screening:
• • 1. Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
• • 2. Heart failure with classified as being in New York Heart Association Class III or IV.
• • 7. Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
• • 8. Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
• • 9. Subject plans to schedule elective surgery during the study.