Clinical trial NCT04984707: Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessments
timeFrame: 3 days
measure: Incidence of treatment-emergent adverse events (TEAE) by vital signs measurements
timeFrame: 3 days
measure: Incidence of treatment-emergent adverse events (TEAE) by ECG assessment
timeFrame: 3 days
measure: Incidence of treatment-emergent adverse events (TEAE) by clinical lab tests
timeFrame: 3 days
measure: Incidence of study drug related TEAEs
timeFrame: 3 days
Secondary outcomes:
measure: AUC from time 0 and extrapolated to infinite time, total exposure(AUCinf)
timeFrame: 48 hours
measure: AUC from time 0 to the last non-zero concentration(AUClast)
timeFrame: 48 hours
measure: Maximum observed concentration (Cmax)
timeFrame: 48 hours
measure: Time at which Cmax was first observed(Tmax)
timeFrame: 48 hours
measure: half life（T½）
timeFrame: 48 hours
measure: Apparent total systemic clearance, calculated as Dose/AUCinf(Cl/F)
timeFrame: 48 hours
measure: Apparent volume of distribution(Vd/F)
timeFrame: 48 hours
measure: elimination rate constant（Kel）
timeFrame: 48 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: inVentiv Health Clinical Research Services LLC
state: Florida
Study officials:
affiliation: inVentiv Health Clinical Research Services,LLC
name: David J Wyatt, MD
role: PRINCIPAL_INVESTIGATOR
References: