safety, tolerability and pharmacokinetics of kx826 in healthy male subjects with androgenetic alopecia following topical single ascending dose administration

Conditions: Androgenetic Alopecia

Summary: the study is a randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy male subjects with androgenetic alopecia to evaluate the safety, tolerability and pharmacokinetics of kx-826 following topical single ascending dose administration

a total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug and 8 subjects randomized to receive placebo in a double-blind fashion (ten subjects in each dose cohort with two subjects randomized to placebo for total of four dose cohorts).subjects were to be assigned to 1 of the 4 dose levels, 3 mg. 12 mg, 48 mg and 96 mg of kx-826 or placebo to match the active product, administered as a topical application.

Eligibility criteria:
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.