A Phase 1 Study of TDM-180935 Following Topical Administration in Healthy Male Subjects

Exclusion Criteria

• •A subject is ineligible to enter the study if he/she meets 1 or more of the following criteria:
• •1. Subject has any dermatological disorders of the skin within 20 cm of the Treatment Areas with the possibility of interfering with the application of the IP or examination method, such as fungal or bacterial infections, psoriasis, eczema, folliculitis, notable scarring (linear scar \> 2.5 cm, etc.), or skin atrophy at Visit 2/Baseline.
• •2. Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the IP or requires use of interfering topical, systemic, or surgical therapy at Visit 2/Baseline.
• •3. Subject has any visible inflammatory skin disease, injury, or condition of their skin that could compromise subject safety and/or interfere with the evaluation of local or systemic assessments performed during the study.
• •4. Subject has a known or suspected malignancy at Visit 2/Baseline excluding basal cell skin cancer unless it is associated with the Treatment Areas per Exclusion Criterion #1.
• •5. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody.
• •6. 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 IP.
• •7. Subject has a hospital admission or major surgery within 30 days prior to Visit 2/ Baseline or planned for during the study.
• •8. Subject is currently enrolled in an investigational drug, biologic, or device study.
• •9. 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.
• •10. Subject has a history of prescription drug abuse, or illicit drug use within 6 months prior to Visit 1/Screening.
• •11. Subject has a history of alcohol abuse according to medical history within 6 months prior to Visit 1/Screening.
• •12. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or Visit 2/Baseline.
• •13. 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.
• •14. Subject has used systemic prescription medications, herbal (including St John's Wort, herbal teas and garlic extracts) supplements within 14 days prior to dosing at Visit 2/Baseline.
• •15. 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).
• •16. Subject has used topical cosmetic (excluding bland moisturizers), herbal, OTC or prescription products within the designated Treatment Areas 1 day prior to dosing at Visit 2/Baseline.
• •17. Subject received a live or live attenuated vaccine within 4 weeks of dosing at Visit 2/Baseline.
• •18. Subject has signs or symptoms consistent with COVID-19 at Visit 1/Screening or Visit 2/Baseline or has been diagnosed with COVID-19 within 4 weeks of Visit 1/Screening.
• •19. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• •20. Subject has previously been treated with the IP.
• •21. Subject has a history of sensitivity to any of the ingredients in the IP.
• •22. Subject has ongoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the investigator's opinion, should exclude participation in the study.