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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324293
• Other study ID #: HMI-115102
• Status: Completed
• Phase: Phase 1
• Start date: May 11, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: October 2023
• Source: Hope Medicine (Nanjing) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• HMI-115
Once Every 2 weeks, subcutaneously injection

Locations

Country	Name	City	State
Australia	Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology	Melbourne E.	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Hope Medicine (Nanjing) Co., Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TAHC(target area hair count) of non-vellus	Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.	From baseline to Week 24
Secondary	TAHC of non-vellus	Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.	From baseline to Week 6, 12, 18, and 36
Secondary	TAHW(target area hair width) of non-vellus hair	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.	From baseline to Week 6, 12, 18, 24, and 36
Secondary	Investigator Global Assessment (IGA)	IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.	Week 6, 12, 18, 24, and 36
Secondary	Subject self-Assessment (SSA)	SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.	Week 6, 12, 18, 24, and 36
Secondary	Hair growth questionnaire assessment (HGQA)	HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.	Week 6, 12, 18, 24, and 36