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| Name | Class |
|---|---|
| DataPharm Australia, CMAX Clinical Research, Agilex Australia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil | Drug | Topical formulation applied once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic data: Cmax | Individual and mean maximum plasma concentration (Cmax) | 7 days |
| Pharmacokinetic data: tmax | Individual and mean tmax | 7 days |
| Pharmacokinetic data: Half-life (t1/2) | Individual and mean half-life (t1/2) | 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) | 7 days |
| Pharmacokinetic data: Drug clearance | Individual and mean apparent clearance of drug from plasma | 7 days |
| Safety : Skin TEAEs | Incidence of treatment-emergent adverse events related to skin irritation at the administration site | 7 days |
| Safety: Systemic TEAEs | Incident of systemic treatment-emergent adverse events | 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
If subjects have a BMI outside of the range of 18-35kg/m2
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 28, 2026 | |
| Reset | May 19, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 19, 2026 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| 7 days |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011461 |
| Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |