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

November 14, 2023 updated by: Hope Medicine (Nanjing) Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne E., Victoria, Australia
        • Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMI-115 240mg
Drug: HMI-115
Once Every 2 weeks, subcutaneously injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Week 6, 12, 18, and 36
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.
From baseline to Week 6, 12, 18, 24, and 36
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.
Week 6, 12, 18, 24, and 36
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.
Week 6, 12, 18, 24, and 36
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.
Week 6, 12, 18, 24, and 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hope Medicine (Nanjing) Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMI-115102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe