This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Part A: SAD and FES study * To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults * To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults Part B: MAD study \- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
IN-114199 2.5mg or placebo (1 Tablet, QD)
IN-114199 10mg or placebo (1 Tablet, QD)
IN-114199 10mg or placebo (2 Tablets, QD)
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
Adverse Event
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Time frame: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)
Vital Sign
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Physical Examination
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Body Weight in kilograms Measurement
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
Time frame: Part I : Up to Day 3 / Part II: Up to Day 9
12-lead electrocardiogram (ECG)
QT/QTc interval will be recorded and analyzed automatically.
Time frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9
Clinical Laboratory Test
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Time frame: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IN-114199 10mg or placebo (4 Tablets, QD)
IN-114199 2.5mg or placebo (2 Tablets, QD)
PK parameters (Urine and Plasma)
Cmax
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PK parameters (Urine and Plasma)
AUClast
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma C4 level)
AUEClast
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
PD parameters (plasma LDL/HDL level)
AUEClast
Time frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8