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

NCT06118866 | Completed Phase 2

• 1 other identifier: HMI-115AG201
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• The Rate of Target Arean Hair Count (TAHC)

  The mean change in TAHC of non-vellus from baseline

  24 Weeks

Secondary Outcomes (19)

• Hair Growth State Assessed by Hair Growth Questionnaire Assessment (HGQA)

  6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks

• Target Area Hair Count (TAHC) change from baseline

  6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks

• Rate of Target Area Hair Width (TAHW)

  6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks

• Investigator Global Assessment (IGA)

  6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks

• Subject Self-Assessment (SSA)

  6 weeks, 12 weeks, 18 weeks, 24 weeks, and 36 weeks

Study Arms (4)

placebo-Q2W

PLACEBO COMPARATOR

placebo, 0mg/vials

Drug: placebo-Q2W

HMI-115-120mg-Q4W

ACTIVE COMPARATOR

HMI-115, 60mg/vials

Drug: HMI-115-120mg-Q4W

HMI-115-240mg-Q4W

ACTIVE COMPARATOR

HMI-115, 60mg/vials

Drug: HMI-115-240mg-Q4W

HMI-115-240mg-Q2W

ACTIVE COMPARATOR

HMI-115, 60mg/vials

Drug: HMI-115, 240mg-Q2W

Interventions

placebo-Q2W DRUG

placebo, 0mg，SC，Q2W，12 cycles

placebo-Q2W

HMI-115-120mg-Q4W DRUG

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

HMI-115-120mg-Q4W

HMI-115-240mg-Q4W DRUG

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

HMI-115-240mg-Q4W

HMI-115, 240mg-Q2W DRUG

HMI-115, 240mg，SC，Q2W，12 cycles

HMI-115-240mg-Q2W

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
• Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
• 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.
• 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.
• 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.

You may not qualify if:

• Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
• Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
• Subject with history of hair weaves within 3 months prior screening.
• Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
• Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure \[SBP\] \> 159 mmHg, diastolic blood pressure \[DBP\] \> 99 mmHg).
• Subject has any of the following conditions within 6 weeks prior to Screening:
• Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
• Heart failure with classified as being in New York Heart Association Class III or IV.
• Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
• Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
• Subject plans to schedule elective surgery during the study.

Sponsors & Collaborators

• Hope Medicine (Nanjing) Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 7, 2023
• Study Start: September 11, 2023
• Primary Completion: August 26, 2024
• Study Completion: November 28, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)