Androgenetic AlopeciaPhase 1NCT05324293
To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period
A Phase 1 study testing HMI-115 in people with Androgenetic Alopecia, run by Hope Medicine (Nanjing) Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- HMI-115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 11 May 2022to 11 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
Melbourne E., Victoria
About this study
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
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- HMI-115
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMI-115Drug
Once Every 2 weeks, subcutaneously injection
| Study group | Role | What they receive |
|---|---|---|
| HMI-115 240mg | Experimental | Not described Receives: Drug: HMI-115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAHC(target area hair count) of non-vellus
Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.
Measured: From baseline to Week 24
Secondary outcomes (5)
TAHC of non-vellus
Change in TAHC of non-vellus from baseline to Week 6, 12, 18, and 36 in male and female, respectively.
Measured: From baseline to Week 6, 12, 18, and 36
TAHW(target area hair width) of non-vellus hair
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.
Measured: From baseline to Week 6, 12, 18, 24, and 36
Investigator Global Assessment (IGA)
IGA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Measured: Week 6, 12, 18, 24, and 36
Subject self-Assessment (SSA)
SSA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Measured: Week 6, 12, 18, 24, and 36
Hair growth questionnaire assessment (HGQA)
HGQA at Week 6, 12, 18, 24, and 36 in male and female, respectively.
Measured: Week 6, 12, 18, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start11 May 2022
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Medicine (Nanjing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324293
- Sponsor's protocol ID
- HMI-115102
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05324293
- Acronym / sponsor ID
- HMI-115102
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hope Medicine (Nanjing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMI-115 240mg | Experimental | Drug: HMI-115 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMI-115Once Every 2 weeks, subcutaneously injection | Drug | HMI-115 240mg |
Primary outcome
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.
5 secondary outcomes
TAHC of non-vellus
Time frame: From baseline to Week 6, 12, 18, and 36
TAHW(target area hair width) of non-vellus hair
Time frame: From baseline to Week 6, 12, 18, 24, and 36
Investigator Global Assessment (IGA)
Time frame: Week 6, 12, 18, 24, and 36
Subject self-Assessment (SSA)
Time frame: Week 6, 12, 18, 24, and 36
Hair growth questionnaire assessment (HGQA)
Time frame: Week 6, 12, 18, 24, and 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMI-115 in people with Androgenetic Alopecia, run by Hope Medicine (Nanjing) Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAHC(target area hair count) of non-vellus (time frame: From baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.