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.
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 and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to receive placebo for a total of 4 dose cohorts). Cohort Dose of KX-826 Subjects 1. 2.5 mg QD for 14 days 10 (8 active + 2 placebo) 2. 5 mg QD for 14 days 10 (8 active + 2 placebo) 3. 10 mg QD for 14 days 10 (8 active + 2 placebo) 4. 20 mg QD for 14 days 10 (8 active + 2 placebo) Dose escalation will not occur until review of the multiple dose safety from the previous dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
inVentiv Health Clinical Research Services LLC
Miami, Florida, United States
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.
Time frame: 19 days
Incidence of study drug related TEAEs
incidence of study drug related TEAEs (possibly, probably or definitely)
Time frame: 19 days
Maximum observed concentration (Cmax)
Pharmacokinetics
Time frame: 1 day
Time at which Cmax was first observed (Tmax)
Pharmacokinetics
Time frame: 1 day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Pharmacokinetics
Time frame: 1 day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Pharmacokinetics
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Time frame: 19 days
Cmax at steady state (Cmax_ss)
Pharmacokinetics
Time frame: 19 days
Time at which Cmax_ss was first observed (Tmax_ss)
Pharmacokinetics
Time frame: 19 days
Minimum observed or "trough" concentration at steady state (Cmin_ss)
Pharmacokinetics
Time frame: 19 days
Average concentration at steady state (Cav_ss)
Pharmacokinetics
Time frame: 19 days
AUC from time 0 and extrapolated to infinite time, total exposure (AUCinf)
Pharmacokinetics
Time frame: 19 days
AUC from time 0 to the last non-zero concentration (AUClast)
Pharmacokinetics
Time frame: 19 days
Biological half-life (T1/2 el)
Pharmacokinetics
Time frame: 19 days
Terminal elimination rate constant (Kel)
Pharmacokinetics
Time frame: 19 days