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
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|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Drug: HMI-115||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: HMI-115 240mg||
Once Every 2 weeks, subcutaneously injection
- 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.
- 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.
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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|
- 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.
- 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
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
|Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology|
|Melbourne E., Victoria, Australia|
|Responsible Party:||Hope Medicine (Nanjing) Co., Ltd|
|Other Study ID Numbers:||
|First Posted:||April 12, 2022 Key Record Dates|
|Last Update Posted:||March 17, 2023|
|Last Verified:||April 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Pathological Conditions, Anatomical