Androgenetic AlopeciaPhase 1NCT05864885
Phase I Study of Safety and Pharmacokinetics of Topical Solution in Subjects With Androgenetic Alopecia
A Phase 1 study testing Minoxidil in people with Androgenetic Alopecia, run by Aneira Pharma, Inc..
Trial summary
This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2023to 17 Jul 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are:
- Migraines
- Non-hospitalized depression o Asthma
- Cholecystectomy
- Gilbert's syndrome
- Clinical diagnosis of AGA with grade II to VI hair loss on Norwood Hamilton Classification System
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- Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator's opinion, interfere with study assessments.
- No known allergy to ANR-001.1 or any of its components.
- Subject is willing to avoid extensive sun exposure, phototherapy, or use of tanning salon for the duration of the study.
Who cannot join
- If subjects have a BMI outside of the range of 18-35kg/m2
- Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study.
- Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator.
- Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation.
- Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.).
- Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test treatment.
- Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
About this study
Official title: Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia
This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.
Read the detailed description
At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG.
At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed.
If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
Also called Latanoprost
Topical formulation applied once a day.
| Study group | Role | What they receive |
|---|---|---|
| Primary safety and pharmacokinetic data | Experimental | To obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp Receives: Drug: Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic data: Cmax
Individual and mean maximum plasma concentration (Cmax)
Measured: 7 days
Pharmacokinetic data: tmax
Individual and mean tmax
Measured: 7 days
Pharmacokinetic data: Half-life (t1/2)
Individual and mean half-life (t1/2)
Measured: 7 days
Pharmacokinetic data: AUC
Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
Measured: 7 days
Pharmacokinetic data: Drug clearance
Individual and mean apparent clearance of drug from plasma
Measured: 7 days
Safety : Skin TEAEs
Incidence of treatment-emergent adverse events related to skin irritation at the administration site
Measured: 7 days
Safety: Systemic TEAEs
Incident of systemic treatment-emergent adverse events
Measured: 7 days
Safety: Evaluation of QTs Interval Prolongation
Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start9 Jun 2023 (estimated)
- Primary completion17 Jul 2023 (estimated)
- Study completion17 Jul 2023 (estimated)
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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aneira Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DataPharm Australia, CMAX Clinical Research, Agilex Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864885
- Sponsor's protocol ID
- ANR C002
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Safety and Pharmacokinetics of Once-Daily Topical Solution in Male Subjects With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT05864885
- Acronym / sponsor ID
- ANR C002
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Aneira Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DataPharm Australia, CMAX Clinical Research, Agilex Australia
- Study start
- 9 Jun 2023 (estimated)
- Primary completion
- 17 Jul 2023 (estimated)
- Study completion
- 17 Jul 2023 (estimated)
- First posted
- 18 May 2023 (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.
This study will be a single center, open-label study of a single concentration of ANR- 001.1. The solution will be applied to the scalp of 14 male subjects by study staff once daily for 7 days.
Detailed description
At screening, subjects will sign informed consent and inclusion and exclusion will be reviewed for each subject. Screening data will include demographics, medical history, concomitant medications, physical examination, weight, O2 sat, vital signs laboratory evaluation (CMP, CBC, UA), and ECG.
At Day 1, a physical exam, weight, O2 sat, vital signs (including BP, pulse, respiratory rate and temperature) and review of concomitant medications will be performed, and admission criteria reviewed.
If criteria are met, the study staff will administer the first dose of study medication to the area of hair loss on the scalp (8 cm x 6 cm). If there is no hair loss the dose will be administered to the crown of the head (8 cm x 6 cm). The study staff will continue to administer the study medication to the same area of the scalp of the subject, once daily for Study Days 1, 2, 3, 4, 5, 6, and 7. Daily subject visits will include vital signs, review of adverse events and concomitant medications. PK draws and ECGs will take place at Study Days 1, 2, 7 and 8, following the first dose and the last doses, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary safety and pharmacokinetic data | Experimental | Drug: MinoxidilTo obtain primary safety and pharmacokinetic data on the ANR- 001.1 when applied topically, once daily, for 7 days to the scalp |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males between age 18 to 65 years, in general good health. Good health is defined as a subject without any active diseases. Not included in active diseases are:
- Migraines
- Non-hospitalized depression o Asthma
- Cholecystectomy
- Gilbert's syndrome
Key exclusion criteria (7 listed)
- If subjects have a BMI outside of the range of 18-35kg/m2
- Subjects using a minoxidil product (e.g., Rogaine or generic Rogaine) or a latanoprost product (e.g., Xalatan or generic Xalatan) within 30 days of the start of Day 1 of the study.
- Subjects whose vital signs, ECG, safety labs or physical exam results are clinically significant in the opinion of the investigator.
- Subjects have a skin condition that, in the Investigators opinion, could interfere with study assessment or put the subject at undue risk by study participation.
- Subjects with an active or recent (within 30 days before Day 1) disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.).
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 |
|---|---|---|
| MinoxidilAlso: LatanoprostTopical formulation applied once a day. | Drug | Primary safety and pharmacokinetic data |
Primary outcome
Pharmacokinetic data: Cmax
Time frame: 7 days
Individual and mean maximum plasma concentration (Cmax)
Pharmacokinetic data: tmax
Time frame: 7 days
Individual and mean tmax
Pharmacokinetic data: Half-life (t1/2)
Time frame: 7 days
Individual and mean half-life (t1/2)
Pharmacokinetic data: AUC
Time frame: 7 days
Individual and mean area under the concentration-time curve calculated from time zero to the last observable concentration at time t (AUC0-t)
Pharmacokinetic data: Drug clearance
Time frame: 7 days
Individual and mean apparent clearance of drug from plasma
Safety : Skin TEAEs
Time frame: 7 days
Incidence of treatment-emergent adverse events related to skin irritation at the administration site
Safety: Systemic TEAEs
Time frame: 7 days
Incident of systemic treatment-emergent adverse events
Safety: Evaluation of QTs Interval Prolongation
Time frame: 7 days
Change from baseline in the frequency of marked QTc prolongation at each visit where ECG is performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minoxidil in people with Androgenetic Alopecia, run by Aneira Pharma, Inc..
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 9 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: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pharmacokinetic data: Cmax (time frame: 7 days). The study lists 8 primary outcomes in all. 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 18 May 2023.