About this trial
This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- IN-114199 2.5mg or placebo
- IN-114199 10mg or placebo
- IN-114199 20mg or placebo
- IN-114199 40mg or placebo
- IN-114199 5mg or placebo
Treatment groups
9
Treatment groupsSee each treatment group below.