CompletedPhase 1

To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period

Australia16 participantsStarted 2022-05-11

Plain-language summary

An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
✓. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.

Exclusion criteria

✕. Subject with clinical diagnosis of non-AGA
✕. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
✕. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
✕. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
✕. Subject has clinically significantly abnormal laboratory tests at Screening
✕. Known hypersensitivity to any of the IMP ingredients
✕. Any other conditions in the investigator's opinion that prevent the subject from participating

What they're measuring

TAHC(target area hair count) of non-vellus

Timeframe: From baseline to Week 24

Trial details

NCT IDNCT05324293

SponsorHope Medicine (Nanjing) Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-11

View on ClinicalTrials.gov More Androgenetic Alopecia trials