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

Phase 1

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: HMI-115

• Registration Number: NCT05324293
• Lead Sponsor: Hope Medicine (Nanjing) Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-12
• Study Start: 2022-05-11
• Primary Completion: 2023-09-11
• Study Completion: 2023-09-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

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
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HMI-115 240mg	HMI-115	-

Primary Outcome Measures

Name	Time	Method
TAHC(target area hair count) of non-vellus	From baseline to Week 24	Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment (IGA)	Week 6, 12, 18, 24, and 36	IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
TAHC of non-vellus	From baseline to Week 6, 12, 18, and 36	Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
TAHW(target area hair width) of non-vellus hair	From baseline to Week 6, 12, 18, 24, and 36	Change in target area hair width (TAHW) of non-vellus hair from baseline to Week 6, 12, 18, 24, and 36 in male and female, respectively.
Subject self-Assessment (SSA)	Week 6, 12, 18, 24, and 36	SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Hair growth questionnaire assessment (HGQA)	Week 6, 12, 18, 24, and 36	HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

Trial Locations

Locations (1)

Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology; 🇦🇺 Melbourne E., Victoria, Australia