The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below: * Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study. * Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study. * Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
oral tablet of CT-G11 Experimental Drug
oral tablet of CT-G20 Experimental Drug
oral tablet of Placebo
oral tablet of Placebo
Seoul National University Hospital
Seoul, South Korea
Incidence of Adverse events including serious Adverse events (Part I, Part II)
Time frame: 46 days
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
Time frame: Up to 48 hours after administration
Safety parameters as assessed by: QT interval of ECG
Time frame: 17 Days
Safety parameters as assessed by: QTcF of ECG
Time frame: 17 Days
Safety parameters as assessed by: blood pressure of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: pulse rate of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: body temperature of Vital signs
Time frame: 17 Days
Safety parameters as assessed by: hematology of Clinical laboratory tests
Time frame: 17 Days
Safety parameters as assessed by: clinical chemistry
Time frame: 17 Days
PK parameters as assessed by : Area under the concentration-time curve (AUC)
Time frame: 13 Days
PK parameters as assessed by : Maximum observed concentration (Cmax)
Time frame: 13 Days
PK parameters as assessed by : Time to Cmax (tmax)
Time frame: 13 Days
PK parameters as assessed by : Terminal half-life time (t1/2)
Time frame: 13 Days
PD parameters as assessed by : Left ventricular ejection fraction (LVEF)
Time frame: 17 Days
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