Status:
COMPLETED
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending
Lead Sponsor:
Suzhou Kintor Pharmaceutical Inc,
Conditions:
Androgenetic Alopecia
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief 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.
Detailed Description
KX-826 topical solution will be applied to the scalp of healthy male subjects with androgenetic alopecia. A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug a...
Eligibility Criteria
Inclusion
- Are capable of giving informed consent and complying with study procedures;
- Are males between the ages of 18 and 60 years, inclusive;
- Have a clinical diagnosis of androgenetic alopecia;
- 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);
- Have normal renal and hepatic function as determined by the screening laboratory results;
- Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
- Body mass index (BMI) of 19.0 to 35.0 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the CRU
Exclusion
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- 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;
- Subject has any dermatological disorders of the scalp;
- Subject has a history of hair transplants, hair weaves;
- Subject has hypersensitivity to previously prescribed minoxidil or finasteride;
- Known or suspected malignancy;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
- A hospital admission or major surgery within 30 days prior to screening;
- Participation in any other investigational drug trial within 30 days prior to screening;
- A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
- A history of alcohol abuse according to medical history within 6 months prior to screening;
- A positive screen for alcohol or drugs of abuse;
- 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;
- 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);
- 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.
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04502901
Start Date
January 14 2020
End Date
January 15 2021
Last Update
August 11 2021
Active Locations (1)
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1
inVentiv Health Clinical Research Services LLC
Miami, Florida, United States, 33136