Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration

Inclusion Criteria: 1. Are capable of giving informed consent and complying with study procedures; 2. Are males between the ages of 18 and 60 years, inclusive; 3. Have a clinical diagnosis of AGA; 4. Considered healthy by the PI, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs; 5. Have normal renal and hepatic function as determined by the screening laboratory results; 6. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening; 7. Body mass index (BMI) of 19.0 to 35.0 kg/m2 inclusive and body weight not less than 50 kg; 8. Willing and able to adhere to study restrictions and to be confined at the clinical research center. Exclusion Criteria: 1. Clinically significant history of gastrointestinal (GI), cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; 2. Any visible skin disease, damage or condition at the application site which, in the opinion of the investigator, could compromise subject safety and/or interfere with the evaluation of the test site reaction; 3. Subject has any dermatological disorders of the scalp; 4. Subject has a history of hair transplants, hair weaves; 5. Subject has hypersensitivity to previously prescribed minoxidil or finasteride; 6. Known or suspected malignancy; 7. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs Ag), or hepatitis C (HCV) antibody; 8. A hospital admission or major surgery within 30 days prior to screening; 9. Participation in any other investigational drug trial within 30 days prior to screening; 10. A history of prescription drug abuse, or illicit drug use within 6 months prior to screening; 11. A history of alcohol abuse according to medical history within 6 months prior to screening; 12. A positive screen for alcohol or drugs of abuse; 13. Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening; 14. Use of prescription or over the counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at \< 3g/day was permitted until 24 hours prior to dosing); 15. An unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation.