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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05324293
Recruitment Status : Not yet recruiting
First Posted : April 12, 2022
Last Update Posted : April 12, 2022
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
 (submitted: April 11, 2022)
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
 (submitted: April 11, 2022)
  • 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
 (submitted: April 11, 2022)
20
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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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