Safety, tolerability, and dosing of IY-828026 in healthy adults

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

This test tries to see how safe and well-tolerated IY-828026 is and how the body absorbs and clears it in healthy adults aged 19 to 50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 19 Years to 50 Years
• Sex: All
• Sponsor: Il-Yang Pharm. Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT07433556 on ClinicalTrials.gov

What this trial studies

This randomized, double-blinded, partially open, placebo- and active-controlled Phase 1 dose-escalation study enrolls healthy adult volunteers to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Participants receive single and multiple escalating doses of IY-828026 or matching controls with planned safety monitoring between cohorts. Serial blood and possibly other samples will be collected to define absorption, distribution, metabolism, elimination, and PD markers. Findings will inform safe dosing and monitoring for subsequent patient-focused trials.

Who should consider this trial

Good fit: Healthy adults aged 19–50 years with BMI 18.5–29.9 kg/m2 and body weight 50–90 kg who can provide informed consent and attend clinic visits are ideal candidates.

Not a fit: Individuals with significant hepatic, renal, cardiac, psychiatric, or other major medical conditions, recent H. pylori treatment/positive test, known hypersensitivity to related drugs, pregnancy, or who fall outside the specified age/weight/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could establish a safe dosing range and PK/PD profile that enables later patient trials and supports future therapeutic development.

How similar studies have performed: Phase 1 dose-escalation PK/PD studies of similar small-molecule agents commonly establish safety and dosing for later phases, but IY-828026 itself is novel and its human effects are untested.

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 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

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: YunSeon Kim

Conditions Healhty