Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

A Randomized, Open-label, Placebo- and Active- Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of JP-1366 Oral Administration in Healthy Male Subjects

Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects

Inclusion Criteria:

• Healthy adult males aged between 19 and 50 at screening
• Weight is between 55 and 90 kg and BMI is between 18.0 and 27.0
• Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

• Subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
• Subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
• Subject has been Helicobacter pylori positive
• AST (SGOT) and ALT (SGPT) > 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization
• Subject has anatomical disability in insertion and maintenance of pH meter catheter