Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers
Recruiting
Phase 1Interventional Study
Healhty
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
Il-Yang Pharm. Co., Ltd. · Industry
Who this trial is looking for
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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
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Eligibility Criteria
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 partic…
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
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