A Study of TDM-105795 in Male Subjects With Androgenetic Alopecia (AGA)

Exclusion Criteria

• •A subject is ineligible to enter the study if he meets 1 or more of the following criteria:
• •1. Subject has any dermatological disorders of the scalp on the regions that are bald and thinning with the possibility of interfering with the application of the test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
• •2. Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns) that, in the investigator's opinion, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
• •3. Subject has any visible inflammatory skin disease, injury, or condition of their scalp that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
• •4. Subject has a history of scalp reduction or notable trauma with related scarring, hair transplants, and/or hair weaves.
• •5. Subject has a known or suspected malignancy.
• •6. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• •7. Subject has any condition, which, in the investigator's opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory or 12-lead electrocardiogram (ECG) findings during the screening period or Visit 2/Baseline prior to dosing of the test article.
• •8. Subject has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
• •9. Subject is currently enrolled in an investigational drug, biologic, or device study.
• •10. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit 2/Baseline.
• •11. Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
• •12. Subject has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
• •13. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline.
• •14. Subject has a donation or blood collection of more than 1 unit (approximately 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to Visit 2/Baseline.
• •15. A. Subject has used systemic inhibitors or inducers of CYP3A4 and Pgp (including rifampicin, rifabutin, St. John's Wort, corticosteroids, and environmental exposure) within 30 days prior to dosing at Visit 2/Baseline. B. Subject drank grapefruit juice within 7 days prior to dosing at Visit 2/Baseline.
• •16. Subject has used systemic prescription medications, herbals (including herbal teas and garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline.
• •17. Subject has used systemic over the counter (OTC) medications or vitamins within 7 days prior to dosing at Visit 2/Baseline. (Note: Use of acetaminophen at \< 3g/day is permitted until 24 hours prior to dosing at Visit 2/Baseline).
• •18. Subject has used any scalp hair growth treatments including medical devices (e.g., LED caps/wands/combs), prescription products (e.g., minoxidil, finasteride, dutasteride, etc.), herbal, homeopathy or other forms of treatment which may affect hair growth (in the opinion of the investigator) within 14 days prior to dosing at Visit 2/Baseline.