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

Hope Medicine

Status and phase: Enrolling; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: HMI-115-240mg-Q4W; Drug: HMI-115-120mg-Q4W; Drug: HMI-115, 240mg-Q2W; Drug: placebo-Q2W

Study type: Interventional

Funder types: Industry

Identifiers

NCT06118866

HMI-115AG201

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 4 patient groups, including a placebo group

placebo-Q2W

Placebo Comparator group

Description:

placebo, 0mg/vials

Treatment:

Drug: placebo-Q2W

HMI-115-120mg-Q4W

Active Comparator group

Description:

HMI-115, 60mg/vials

Treatment:

Drug: HMI-115-120mg-Q4W

HMI-115-240mg-Q4W

Active Comparator group

Description:

HMI-115, 60mg/vials

Treatment:

Drug: HMI-115-240mg-Q4W

HMI-115-240mg-Q2W

Active Comparator group

Description:

HMI-115, 60mg/vials

Treatment:

Drug: HMI-115, 240mg-Q2W