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

Phase 1

Completed

• Conditions: Androgenetic Alopecia; Skin - Dermatological conditions

• Registration Number: ACTRN12622000680763
• Lead Sponsor: Hope Medicine (Nanjing) Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-11
• Study Completion: 2023-09-11
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified