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

Last updated: September 4, 2024
Sponsor: Hope Medicine (Nanjing) Co., Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Scalp Disorders

Male Pattern Baldness

Hair Loss

Treatment

HMI-115-120mg-Q4W

placebo-Q2W

HMI-115, 240mg-Q2W

Clinical Study ID

NCT06118866
HMI-115AG201
  • Ages 18-65
  • Male

Study Summary

To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Male subjects, between 18 and 65 years of age, inclusive, at the time of signinginformed consent.

  3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamiltonscales III vertex, IV and V .

  4. 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.

  5. 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.

  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 islonger.

Exclusion

Exclusion Criteria:

  1. Subject with history of scalp radiation or surgery which could interfere studyassessment (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 (systolicblood pressure [SBP] > 159 mmHg, diastolic blood pressure [DBP] > 99 mmHg).

  6. Subject has any of the following conditions within 6 weeks prior to Screening:

  7. Myocardial infarction, stroke, unstable angina, or transient ischemic attack.

  8. Heart failure with classified as being in New York Heart Association Class IIIor IV.

  9. Subject has high fever, major surgery, or ten percent or more weight decrease withinthree months before screening.

  10. Subject with history of active malignancy (with or without systemic chemotherapy),except treated basal cell carcinoma of the skin (besides scalp).

  11. Subject plans to schedule elective surgery during the study.

Study Design

Total Participants: 180
Treatment Group(s): 4
Primary Treatment: HMI-115-120mg-Q4W
Phase: 2
Study Start date:
September 11, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100035
    China

    Active - Recruiting

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