the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending

• Status: Completed
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: Male

Summary

The study is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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 androgenetic alopecia;

4. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate ≥45 and ≤100 bpm; one repeat allowed to confirm out of range values);

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 CRU

Exclusion Criteria:

1. Clinically significant history of gastrointestinal, 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 (HBsAg), or hepatitis C virus (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 is 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.