NCT07433556 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers
| NCT ID | NCT07433556 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Il-Yang Pharm. Co., Ltd. |
| Condition | Healhty |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 86 participants in total. It began in 2026-03-23 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Contact & Investigator
Shin
STUDY DIRECTOR
Ilyang Pharmaceutical
Frequently Asked Questions
Who can join the NCT07433556 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 50 Years, studying Healhty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07433556 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07433556 currently recruiting?
Yes, NCT07433556 is actively recruiting participants. Contact the research team at yskim@ilyang.co.kr for enrollment information.
Where is the NCT07433556 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07433556 clinical trial?
NCT07433556 is sponsored by Il-Yang Pharm. Co., Ltd.. The principal investigator is Shin at Ilyang Pharmaceutical. The trial plans to enroll 86 participants.