The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
oral administration, single dose, 25 mg 1 tab
oral administration, single dose, 25 mg 2 tabs
oral administration, single dose, 100 mg 1 tab
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Number of reported adverse events
Time frame: from day 1 to day 15
Maximum plasma concentration (Cmax) of KL1333
Time frame: from day 1 to day 15
Area Under the Curve (AUC) of KL1333
Time frame: from day 1 to day 15
Half-life (T1/2) of KL1333
Time frame: from day 1 to day 15
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oral administration, single dose, 100 mg 2 tabs
oral administration, single dose, 100 mg 4 tabs
oral administration, single dose, 100 mg 6 tabs
oral administration, single dose, 100 mg 8 tabs
oral administration, placebo