To Evaluate the Safety, Tolerability and Efficacy in Male... | NCT05324293

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

NCT05324293

Sponsor

Hope Medicine (Nanjing) Co., Ltd

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Androgenetic Alopecia

Interventions

HMI-115

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2022Actual

Primary Completion Date

Sep 11, 2023Actual

Completion Date

Sep 11, 2023Actual

First Submitted Date

Mar 30, 2022

First Submission Date that Met QC Criteria

Apr 11, 2022

First Posted Date

Apr 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
HMI-115 240mg	Experimental		Drug: HMI-115

Name	Type	Description	Arm Group Labels	Other Names
HMI-115	Drug	Once Every 2 weeks, subcutaneously injection	HMI-115 240mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
TAHW(target area hair width) of non-vellus hair

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology		Melbourne E.	Victoria		Australia

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided