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

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

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

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Other: Placebo; Drug: KX0826

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • inVentiv Health Clinical Research Services LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group -KX0826; KX0826 is tropically applied to the scalp of healthy male subjects with Androgenetic Alopecia with a single dose.The applied dosage cohorts are 3mg, 12mg, 48mg and 96mg.	Drug: KX0826; AR antagonist; Other Names: Pyrilutamide; KX-826
Placebo Comparator: Control Group- Placebo; Placebo is tropically applied to the scalp of healthy male subjects with Androgenetic Alopecia with a single dose.	Other: Placebo; Placebo of KX-826

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessments	Skin irritation assessments will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation.	3 days
Incidence of treatment-emergent adverse events (TEAE) by vital signs measurements	vital signs (including blood pressure, pulse rate, respiratory rate and oral temperatures)	3 days
Incidence of treatment-emergent adverse events (TEAE) by ECG assessment	12-lead ECG	3 days
Incidence of treatment-emergent adverse events (TEAE) by clinical lab tests	hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings)	3 days
Incidence of study drug related TEAEs	incidence of study drug related TEAEs (possibly, probably or definitely)	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC from time 0 and extrapolated to infinite time, total exposure(AUCinf)	Pharmacokinetics	48 hours
AUC from time 0 to the last non-zero concentration(AUClast)	Pharmacokinetics	48 hours
Maximum observed concentration (Cmax)	Pharmacokinetics	48 hours
Time at which Cmax was first observed(Tmax)	Pharmacokinetics	48 hours
half life（T½）	Pharmacokinetics	48 hours
Apparent total systemic clearance, calculated as Dose/AUCinf(Cl/F)	Pharmacokinetics	48 hours
Apparent volume of distribution(Vd/F)	Pharmacokinetics	48 hours
elimination rate constant（Kel）	Pharmacokinetics	48 hours

Collaborators and Investigators

• Sponsor: Suzhou Kintor Pharmaceutical Inc,
• Investigators: Principal Investigator: David J Wyatt, MD, inVentiv Health Clinical Research Services,LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): April 11, 2019
• Study Completion (Actual): October 24, 2019

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: KX0826-US-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No