This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-63
SponsorHK inno.N Corporation

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

80 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators