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Trial registered on ANZCTR


Registration number
ACTRN12622000680763
Ethics application status
Approved
Date submitted
31/03/2022
Date registered
11/05/2022
Date last updated
15/10/2023
Date data sharing statement initially provided
11/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public 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
Scientific title
To evaluate the safety, tolerability and efficacy in male and female with androgenetic alopecia treated with HMI-115 over a 24-week treatment period
Secondary ID [1] 306793 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 325861 0
Condition category
Condition code
Skin 323173 323173 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eligible subjects will receive HMI-115 240 mg once every two weeks, subcutaneous injection during onsite visit by pharmacist, during the treatment period of 24 weeks.

Intervention code [1] 323256 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330925 0
Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female Androgenetic Alopecia (AGA) subjects through photo review, respectively.
Timepoint [1] 330925 0
Baseline, 24 weeks post-intervention commencement
Secondary outcome [1] 408106 0
Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female through photo review, respectively.
Timepoint [1] 408106 0
Baseline, and weeks 6, 12, 18, and 36 post-intervention commencement
Secondary outcome [2] 408235 0
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 through photo review, respectively.
Timepoint [2] 408235 0
Baseline, and weeks 6, 12, 18, 24, and 36 post-intervention commencement.
Secondary outcome [3] 408236 0
Investigator Global Assessment (IGA) will be assessed by investigator, to evaluate the change in hair growth over time as compared to Baseline, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased).
Timepoint [3] 408236 0
Weeks 6, 12, 18, 24, and 36 post-intervention commencement.
Secondary outcome [4] 408464 0
Subject Self-Assessment (SSA) IGA will be assessed by subject, to evaluate the change in hair growth over time as compared to Baseline, using a 7-point scale from -3 (greatly decreased) to +3 (greatly increased).
Timepoint [4] 408464 0
Weeks 6, 12, 18, 24, and 36 post-intervention commencement.
Secondary outcome [5] 408465 0
Hair Groutth questionnaire assessment (HGQA) is a subject-completed assessment that asks the subject to evaluate his hair growth and quality since the start of the study, using a study specific questionnaire.
Timepoint [5] 408465 0
Weeks 6, 12, 18, 24, and 36 post-intervention commencement.
Secondary outcome [6] 408466 0
safety and tolerability of HMI-115 as assessed by vital signs, physical examinations, concomitant medication, electrocardiogram, clinical laboratory test and review of adverse events.
Vital signs include blood pressure assessed by sphygmomanmeter, tympanic body temperature assessed by thermometer, pulse, and respiratory rate

Concomitant medication will be collected by participant self-report during the visit.

Clinical laboratory tests include Hematology, Coagulation, Clinical Chemistry, Additional Chemistry, Sex hormone, Viral serology, Pharmacokinetics (PK) and Anti-drug Antibody (ADA) of serum , Urinalysis of urine, pregnancy test of serum and urine.

The intensity of AEs will be assessed by investigator using the categories as mild, moderate and severe.
Timepoint [6] 408466 0
the frequency of Vital signs, concomitant medication, and adverse events: every 2 weeks from baseline to 36 weeks post-intervention commencement

the frequency of clinical laboratory tests: 4, 12, 20, 24, and 36 weeks post-intervention commencement

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 (Androgenetic Alopecia_
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 therapy with confirmed effects on PRL level, within defined time window before screening.
4. Subject with history of another pituitary, posterior pituitary, or hyperthyroidism
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP (Investigational Medicinal Product) 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
Non-randomised trial
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2022
Actual
22/07/2022
Date of last participant enrolment
Anticipated
4/10/2022
Actual
17/11/2022
Date of last data collection
Anticipated
6/09/2023
Actual
11/09/2023
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311099 0
Commercial sector/Industry
Name [1] 311099 0
Hope Medicine (Nanjing) Co., Ltd
Country [1] 311099 0
China
Primary sponsor type
Commercial sector/Industry
Name
Hope Medicine (Nanjing) Co., Ltd
Address
Building 16-B2-1 of Tree House Headquarter, No.73 Tanmi Road, Jiangbei New Area, Nanjing City 400025
Country
China
Secondary sponsor category [1] 312427 0
Commercial sector/Industry
Name [1] 312427 0
Clinipace Australia Pty Ltd
Address [1] 312427 0
Suite 12 Level 12 / 37 Bligh Street Sydney NSW 2000
Country [1] 312427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310632 0
Bellberry Limited
Ethics committee address [1] 310632 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 310632 0
Australia
Date submitted for ethics approval [1] 310632 0
22/12/2021
Approval date [1] 310632 0
09/03/2022
Ethics approval number [1] 310632 0
2021-11-1331

Summary
Brief summary
HMI-115 re-established the growth phase for hair follicles to stimulate hair regrowth through blocking the function of prolactin on hair follicles. it is expected that HMI-115 will resolve current clinical unmet needs, not only provide excellent and durable efficacy of hair growth for man and women, but also provide a favorable safety profile. This study aims to explore the preliminary efficacy and safety of HMI-115 in male and female AGA patients aged 18 to 65 years (inclusive) at 240 mg every 2 weeks (Q2W).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118330 0
Dr Rodney Daniel Sinclair
Address 118330 0
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Level 3, 2 Wellington Parade,
East Melbourne VIC 3002
Country 118330 0
Australia
Phone 118330 0
+61396542426
Fax 118330 0
Email 118330 0
[email protected]
Contact person for public queries
Name 118331 0
HopeMed Clinical Trial Posting Group
Address 118331 0
Hope Medicine (Nanjing) Co.,Ltd.
Room 306, Building Y1, No. 112 Liangxiu Road, Pudong New Area, Shanghai China 201203
Country 118331 0
China
Phone 118331 0
+86 21 50760962
Fax 118331 0
Email 118331 0
[email protected]
Contact person for scientific queries
Name 118332 0
HopeMed Clinical Trial Posting Group
Address 118332 0
Hope Medicine (Nanjing) Co.,Ltd.
Room 306, Building Y1, No. 112 Liangxiu Road, Pudong New Area, Shanghai China 201203
Country 118332 0
China
Phone 118332 0
+86 21 50760962
Fax 118332 0
Email 118332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.