Assessing HMI-115 for treating male pattern baldness

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

This study tests if a new treatment called HMI-115 can help men with male pattern baldness grow more hair over 24 weeks compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Hope Medicine (Nanjing) Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06118866 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of HMI-115 in male subjects diagnosed with androgenetic alopecia over a 24-week period. Participants will be randomly assigned to receive either HMI-115 at varying dosages or a placebo, with treatments administered at specified intervals. The study aims to evaluate the effectiveness of HMI-115 in promoting hair growth compared to no treatment. Participants will undergo assessments to monitor their response to the treatment throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are male individuals aged 18 to 65 with a clinical diagnosis of androgenetic alopecia classified as Norwood-Hamilton scales III vertex, IV, or V.

Not a fit: Patients with other types of hair loss or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective solution for men suffering from androgenetic alopecia, potentially restoring hair growth.

How similar studies have performed: Other studies have shown promise in treating androgenetic alopecia with similar therapeutic approaches, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing

• Peking University People's Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: James Fan

Conditions Androgenetic Alopecia