Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects

A Dose-block Randomized, Double-blind, Placebo/Active-controlled, Single/Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and PKs/PDs of YH4808 After Oral Administration in Healthy Male Subjects

First in human study

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of YH4808 in healthy subjects.

Inclusion Criteria:

• Healthy male volunteers in the age between 20 to 45 years old
• Subjects who were determined to be appropriate through screening
• Weight: over 50kg, within ±20% of ideal body weight
• Subjects who signed written consent after receiving thorough explanation on trial purpose, content, and characteristics of investigational drug

Exclusion Criteria:

• Clinically significant disorder in liver, kidney, cardiovascular, respiratory system, endocrine system and CNS in the physical examination and clinical laboratory tests or a medical history of malignant tumor or psychological disease
• Medical history of gastrointestinal disease or acid restraining surgery, gastric/esophagus surgery (excluding appendectomy, hernia surgery)
• A history of hypersensitivity to drugs or clinically significant allergic disease
• Clinically significant abnormal values in blood chemistry(≥ 1.5 fold of normal upper limit in the levels of SGOT, SGPT)
• Subjects who were unable to be applicable for pH meter catheter
• Subjects who had a history of drug abuse or who had a positive results on urine drug screening
• Subjects who had taken usual dose of any prescription drugs within 14 days before the treatment or who had used usual dose of OTC drugs within 7 days before the treatment(cf, be able to be enrolled in this study according to an investigatory consideration)
• Subjects who participated in another clinical trial within 3 months before enrolling in this study
• Subjects who donated whole blood within 2 months or component blood within 1 month or who are donated within 1 month before the treatment
• Subjects who drank Over 21 units/week of alcohol or subjects who weren't able to stop drinking alcohol during the hospitalization
• Subjects who stopped smoking within 3 months before the treatment
• Subjects who had a beverage containing grapefruits within 24hrs before the hospitalization or who had a beverage containing grapefruits during the hospitalization
• Subjects who had a beverage containing caffeine during the hospitalization
• H.pylori positive results on the Urease breath test(Only repeat doses)
• Subjects with clinically significant observations considered as unsuitable based on medical judgment by investigators