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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05324293




Registration number
NCT05324293
Ethics application status
Date submitted
30/03/2022
Date registered
12/04/2022
Date last updated
15/11/2023

Titles & IDs
Public title
To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period
Scientific 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 ID [1] 0 0
HMI-115102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HMI-115

Experimental: HMI-115 240mg -


Treatment: Drugs: HMI-115
Once Every 2 weeks, subcutaneously injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TAHC(target area hair count) of non-vellus
Timepoint [1] 0 0
From baseline to Week 24
Secondary outcome [1] 0 0
TAHC of non-vellus
Timepoint [1] 0 0
From baseline to Week 6, 12, 18, and 36
Secondary outcome [2] 0 0
TAHW(target area hair width) of non-vellus hair
Timepoint [2] 0 0
From baseline to Week 6, 12, 18, 24, and 36
Secondary outcome [3] 0 0
Investigator Global Assessment (IGA)
Timepoint [3] 0 0
Week 6, 12, 18, 24, and 36
Secondary outcome [4] 0 0
Subject self-Assessment (SSA)
Timepoint [4] 0 0
Week 6, 12, 18, 24, and 36
Secondary outcome [5] 0 0
Hair growth questionnaire assessment (HGQA)
Timepoint [5] 0 0
Week 6, 12, 18, 24, and 36

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/09/2023
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology - Melbourne E.
Recruitment postcode(s) [1] 0 0
- Melbourne E.

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hope Medicine (Nanjing) Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05324293
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries