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

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ClinicalTrials.gov Identifier: NCT05324293

Recruitment Status : Not yet recruiting

First Posted : April 12, 2022

Last Update Posted : April 12, 2022

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Sponsor:

Information provided by (Responsible Party):

Hope Medicine (Nanjing) Co., Ltd

Tracking Information

First Submitted Date ^ICMJE

March 30, 2022

First Posted Date ^ICMJE

April 12, 2022

Last Update Posted Date

April 12, 2022

Estimated Study Start Date ^ICMJE

April 2022

Estimated Primary Completion Date

July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

TAHC(target area hair count) of non-vellus [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

TAHC of non-vellus [ Time Frame: 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 [ Time Frame: 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.
Investigator Global Assessment (IGA) [ Time Frame: Week 6, 12, 18, 24, and 36 ]
IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Subject self-Assessment (SSA) [ Time Frame: 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) [ Time Frame: Week 6, 12, 18, 24, and 36 ]
HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Androgenetic Alopecia

Intervention ^ICMJE

Drug: HMI-115

Once Every 2 weeks, subcutaneously injection

Study Arms ^ICMJE

Experimental: HMI-115 240mg

Intervention: Drug: HMI-115

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 2024

Estimated Primary Completion Date

July 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Subject with clinical diagnosis of non-AGA
Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
Subject has clinically significantly abnormal laboratory tests at Screening
Known hypersensitivity to any of the IMP ingredients
Any other conditions in the investigator's opinion that prevent the subject from participating

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Listed Location Countries ^ICMJE

Australia

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05324293

Other Study ID Numbers ^ICMJE

HMI-115102

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Hope Medicine (Nanjing) Co., Ltd

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Hope Medicine (Nanjing) Co., Ltd

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Hope Medicine (Nanjing) Co., Ltd

Verification Date

April 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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