The purpose of this study is to investigate the safety and pharmacokinetics of KM-023 after single/multiple dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
-KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.
-Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea
Safety/ Tolerability Evaluation
-number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis), circulating immune complexes (CIC)
Time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Pharmacokinetic Evaluation of KM-023, Area under the plasma concentration versus time curve (AUC) of KM-023
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate AUC of KM-023
Time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
Pharmacokinetic Evaluation of KM-023, Peak Plasma Concentration (Cmax) of KM-023
-Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted pre-dose through post dose in order to evaluate Cmax of KM-023
Time frame: participants will be followed for the duration of hospital stay, 8-10 days for SAD and 14-16 days for MAD
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