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

Primary Purpose

Androgenetic Alopecia

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
HMI-115
Sponsored by
Hope Medicine (Nanjing) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HMI-115 240mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

TAHC of non-vellus
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
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)
IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Subject self-Assessment (SSA)
SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Hair growth questionnaire assessment (HGQA)
HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.

Full Information

First Posted
March 30, 2022
Last Updated
October 16, 2023
Sponsor
Hope Medicine (Nanjing) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05324293
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
September 11, 2023 (Actual)
Study Completion Date
October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Medicine (Nanjing) Co., Ltd

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMI-115 240mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HMI-115
Intervention Description
Once Every 2 weeks, subcutaneously injection
Primary Outcome Measure Information:
Title
TAHC(target area hair count) of non-vellus
Description
Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.
Time Frame
From baseline to Week 24
Secondary Outcome Measure Information:
Title
TAHC of non-vellus
Description
Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
Time Frame
From baseline to Week 6, 12, 18, and 36
Title
TAHW(target area hair width) of non-vellus hair
Description
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.
Time Frame
From baseline to Week 6, 12, 18, 24, and 36
Title
Investigator Global Assessment (IGA)
Description
IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Time Frame
Week 6, 12, 18, 24, and 36
Title
Subject self-Assessment (SSA)
Description
SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Time Frame
Week 6, 12, 18, 24, and 36
Title
Hair growth questionnaire assessment (HGQA)
Description
HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Time Frame
Week 6, 12, 18, 24, and 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
City
Melbourne E.
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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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