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A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT06118866•Hope Medicine (Nanjing) Co., Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

MALE

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).
+1 more criteria

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

September 11, 2023

Primary Completion Date

August 26, 2024

Completion Date

November 28, 2024

Last Updated

June 4, 2025

Enrollment

192

ACTUAL participants

Conditions

Androgenetic Alopecia

Interventions

placebo-Q2W

DRUG

HMI-115-120mg-Q4W

DRUG

HMI-115-240mg-Q4W

DRUG

HMI-115, 240mg-Q2W

DRUG

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

NCT07012486

Androgenetic Alopecia (AGA)

View study

ACTIVE_NOT_RECRUITINGPHASE2

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

NCT07011485

Alopecia, AndrogeneticBaldness+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia

Combined Use of Povidone-Iodine and Rifampicin in Hair Transplantation

Exosome Treatment in Androgenetic Alopecia

Assessing the Safety and Efficacy of a Novel Microneedling and Laser Device for Male Pattern Hair Loss