Androgenetic Alopecia Clinical Trial
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 PK of KX-826 Following Topical Multiple Dose Ascending
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. ;
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