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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-11-28

Brief Summary

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

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Detailed Description

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo-Q2W

placebo, 0mg/vials

Group Type PLACEBO_COMPARATOR

placebo-Q2W

Intervention Type DRUG

placebo, 0mg，SC，Q2W，12 cycles

HMI-115-120mg-Q4W

HMI-115, 60mg/vials

Group Type ACTIVE_COMPARATOR

HMI-115-120mg-Q4W

Intervention Type DRUG

HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)

HMI-115-240mg-Q4W

HMI-115, 60mg/vials

Group Type ACTIVE_COMPARATOR

HMI-115-240mg-Q4W

Intervention Type DRUG

HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)

HMI-115-240mg-Q2W

HMI-115, 60mg/vials

Group Type ACTIVE_COMPARATOR

HMI-115, 240mg-Q2W

Intervention Type DRUG

HMI-115, 240mg，SC，Q2W，12 cycles

Interventions

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placebo-Q2W

placebo, 0mg，SC，Q2W，12 cycles

Intervention Type DRUG

HMI-115-120mg-Q4W

HMI-115, 120mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)

Intervention Type DRUG

HMI-115-240mg-Q4W

HMI-115, 240mg，SC，Q4W，6 cycles(Placebo given in the second week of each cycle)

Intervention Type DRUG

HMI-115, 240mg-Q2W

HMI-115, 240mg，SC，Q2W，12 cycles

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No