Overview
A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of IY-828026 in healthy adult volunteers
Eligibility
Inclusion Criteria:
- Healthy adult volunteers aged ≥ 19 and ≤ 50 years at screening
- Body weight ≥ 50.0 kg to ≤ 90.0 kg and body mass index (BMI) of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2 at screening
- Volunteers who were fully informed of and completely understood this study, voluntarily agreed to participate, and provided written consent to comply with the precautions
Exclusion Criteria:
- Current or history of clinically significant disease of hepatobiliary (severe hepatic impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), nervous, immune, respiratory, gastrointestinal, endocrine, hemato-oncologic, cardiovascular (heart failure, torsades de pointes, etc.), urinary, or psychiatric (mood disorder, obsessive compulsory disorder, etc.) system or sexual dysfunctions
- H. pylori eradication treatment within 6 months or positive result for H. pylori at screening
- Hypersensitivity or history of clinically significant hypersensitivity to PPIs, P-CABs, and other drugs (aspirin, antibiotics, etc.)
- A positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus \[HIV\] tests, or syphilis tests)
- History of drug abuse or positive results for drug abuse in the urine drug screen
