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

To evaluate the safety, tolerability and efficacy in male and female with androgenetic alopecia treated with HMI-115 over a 24-week treatment period

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000680763

Enrollment

Registered

2022-05-11

Start date

2022-07-22

Completion date

2022-11-17

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

HMI-115 re-established the growth phase for hair follicles to stimulate hair regrowth through blocking the function of prolactin on hair follicles. it is expected that HMI-115 will resolve current clinical unmet needs, not only provide excellent and durable efficacy of hair growth for man and women, but also provide a favorable safety profile. This study aims to explore the preliminary efficacy and safety of HMI-115 in male and female AGA patients aged 18 to 65 years (inclusive) at 240 mg every 2 weeks (Q2W).

Interventions

All eligible subjects will receive HMI-115 240 mg once every two weeks, subcutaneous injection during onsite visit by pharmacist, during the treatment period of 24 weeks.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

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 and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent. 3. 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

1. Subject with clinical diagnosis of non-AGA (Androgenetic Alopecia_ 2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment 3. Subject has used therapies associated with hair growth or therapy with confirmed effects on PRL level, within defined time window before screening. 4. Subject with history of another pituitary, posterior pituitary, or hyperthyroidism 5. Subject has clinically significantly abnormal laboratory tests at Screening 6. Known hypersensitivity to any of the IMP (Investigational Medicinal Product) ingredients 7. Any other conditions in the investigator's opinion that prevent the subject from participating

Outcome results