Overview

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

Status:
Not yet recruiting

Trial end date:
2024-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hope Medicine (Nanjing) Co., Ltd

Criteria

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

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 may affect PRL levels,
within defined time window before Screening

4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic
dysfunction

5. Subject has clinically significantly abnormal laboratory tests at Screening

6. Known hypersensitivity to any of the IMP ingredients

7. Any other conditions in the investigator's opinion that prevent the subject from
participating