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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05324293
Recruitment Status : Active, not recruiting
First Posted : April 12, 2022
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Hope Medicine (Nanjing) Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: HMI-115 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : March 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HMI-115 240mg Drug: HMI-115
Once Every 2 weeks, subcutaneously injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05324293


Locations
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Australia, Victoria
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Melbourne E., Victoria, Australia
Sponsors and Collaborators
Hope Medicine (Nanjing) Co., Ltd
More Information
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Responsible Party: Hope Medicine (Nanjing) Co., Ltd
ClinicalTrials.gov Identifier: NCT05324293    
Other Study ID Numbers: HMI-115102
First Posted: April 12, 2022    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical