To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-11… (NCT05324293) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.