This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Healthy adults aged ≥ 19 years and ≤ 63 years on the date of the written informed consent
Healthy subjects were defined as individuals who defecated almost every day for ≥ 6 months
Body weight of ≥ 40.0 kg and ≤ 100.0 kg, with body mass index (BMI) of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
Those who have fully understood this clinical trial via detailed explanation, were willing to voluntarily participate in this study, and agreed to give written informed consent prior to the screening procedure.
Presence or history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system or psychiatric disease
Presence or history of gastrointestinal disorder (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) that may influence the safety and pharmacodynamic assessments of the investigational product and history of gastrointestinal surgery (except simple appendectomy and hernia surgery), hemostatic disorder or hemorrhage-related disease
Hypersensitivity to drugs including the ingredients of the investigational product and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
Positive result in serology tests (Hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
Sequential
IN-114199 2.5mg or placebo
DrugIN-114199 2.5mg or placebo (1 Tablet, QD)
IN-114199 10mg or placebo
DrugIN-114199 10mg or placebo (1 Tablet, QD)
IN-114199 20mg or placebo
DrugIN-114199 10mg or placebo (2 Tablets, QD)
IN-114199 40mg or placebo
DrugIN-114199 10mg or placebo (4 Tablets, QD)
IN-114199 5mg or placebo
DrugIN-114199 2.5mg or placebo (2 Tablets, QD)
9
Treatment groupsSee each treatment group below.
Adverse Event
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
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
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.
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
PK parameters (Urine and Plasma)
Cmax
PK parameters (Urine and Plasma)
AUClast
PD parameters (plasma C4 level)
AUEClast
PD parameters (plasma LDL/HDL level)
AUEClast
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
