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

NCT04502901 | Completed Phase 1 FDA Drug

• 1 other identifier: KX0826-US-1002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments

  skin irritation assessment 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. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, 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) during the treatment period will be recorded and reported.

  19 days

• Incidence of study drug related TEAEs

  incidence of study drug related TEAEs (possibly, probably or definitely)

  19 days

Secondary Outcomes (12)

• Maximum observed concentration (Cmax)

  1 day

• Time at which Cmax was first observed (Tmax)

  1 day

• Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)

  1 day

• Area under the concentration curve for on dosing interval at steady state (AUC0-t)

  19 days

• Cmax at steady state (Cmax_ss)

  19 days

Study Arms (2)

Experimental Group -KX0826

EXPERIMENTAL

KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg.

Drug: KX0826

Control Group- Placebo

PLACEBO COMPARATOR

Placebo is tropically applied to the scalp of healthy male subjects once a day for 14 days.

Other: Placebo

Interventions

KX0826 DRUG

investigational 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: Yes
• 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 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

You may not qualify if:

• 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.

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

• Phoebe Zhang

  Suzhou Kintor Pharmaceuticals Inc.

  STUDY DIRECTOR

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 31, 2020
• First Posted: August 6, 2020
• Study Start: January 14, 2020
• Primary Completion: August 11, 2020
• Study Completion: January 15, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)