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

NCT04984707 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: KX0826-US-1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• AUC from time 0 and extrapolated to infinite time, total exposure(AUCinf)

  48 hours

• AUC from time 0 to the last non-zero concentration(AUClast)

  48 hours

• Maximum observed concentration (Cmax)

  48 hours

• Time at which Cmax was first observed(Tmax)

  48 hours

• half life（T½）

  48 hours

Study Arms (2)

Experimental Group -KX0826

EXPERIMENTAL

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

Control Group- Placebo

PLACEBO COMPARATOR

Placebo is tropically applied to the scalp of healthy male subjects with Androgenetic Alopecia with a single dose.

Other: Placebo

Interventions

KX0826 DRUG

AR antagonist

Also known as: Pyrilutamide, KX-826

Experimental Group -KX0826

Placebo OTHER

Placebo of KX-826

Control Group- Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 AGA;
• Considered healthy by the PI, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
• 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 clinical research center.

You may not qualify if:

• Clinically significant history of gastrointestinal (GI), 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 (HBs Ag), or hepatitis C (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 was 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.

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (1)

inVentiv Health Clinical Research Services LLC

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David J Wyatt, MD

  inVentiv Health Clinical Research Services,LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 30, 2021
• Study Start: January 28, 2019
• Primary Completion: April 11, 2019
• Study Completion: October 24, 2019
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)