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History of Changes for Study: NCT05324293
To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
Latest version (submitted April 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 11, 2022 None (earliest Version on record)
Comparison Format:

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Study NCT05324293
Submitted Date:  April 11, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: HMI-115102
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Not yet recruiting
Study Start: April 2022
Primary Completion: July 2023 [Anticipated]
Study Completion: March 2024 [Anticipated]
First Submitted: March 30, 2022
First Submitted that
Met QC Criteria:
April 11, 2022
First Posted: April 12, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 11, 2022
Last Update Posted: April 12, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hope Medicine (Nanjing) Co., Ltd
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Androgenetic Alopecia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: HMI-115 240mg Drug: HMI-115
Once Every 2 weeks, subcutaneously injection
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations: Australia, Victoria
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Melbourne E., Victoria, Australia
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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