Healthy Subjects Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, 2-Part, Single Ascending Dose and Multiple Dose Cohort Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10
subjects will be enrolled in each cohort and will be randomly assigned to receive a single
oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review
all available safety data in a blinded manner following the completion of each cohort to
determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned
to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an
adequate number of days to reach steady state (the number of days will be determined based on
the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the
SRT.
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