CompletedPhase 2

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

China192 participantsStarted 2023-09-11

Plain-language summary

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

Age range18 Years – 65 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

The Rate of Target Arean Hair Count (TAHC)

Timeframe: 24 Weeks

NCT IDNCT06118866

SponsorHope Medicine (Nanjing) Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-26

Who can participate

Age range18 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.