Overview

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

Status:
Completed
Trial end date:
2019-10-24
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Suzhou Kintor Pharmaceutical Inc,
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.