Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07433556

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healhty

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Injin Jang, M.D./Ph.D.

CONTACT

[email protected]

82-2-2027-4269

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IY-828026

Drug

IY-828026

Placebo

Drug

Placebo comparator

IY-828026A

Drug

Active comparator

IY-828026B

Drug

Active comparator

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Approximately Day 9 for SAD and Day 15 for MAD

    All adverse events occurring during the clinical trial following a single or multiple ascending dose of IY-828026 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product.

    Events will be coded using MedDRA System Organ Class and Preferred Term.

    [Unit of Measure] Participants

  2. Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

    Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026

    [Unit of Measure] ng/mL

  3. Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

    AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026

    [Unit of Measure] ng·h/mL

  4. Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

    AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026

    [Unit of Measure] ng·h/mL

  5. Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

    Tmax will be derived from the plasma concentration-time profile following a single ascending dose of IY-828026

  6. Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

    Terminal elimination half-life will be estimated from the terminal phase of the concentration-time curve following a single ascending dose of IY-828026

    [Unit of Measure] Hour (h)

  7. Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)

    Cmax,ss will be measured at steady state during multiple ascending dosing (Day 1-7).

    [Unit of Measure] ng/mL

  8. Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)

    AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7)

    [Unit of Measure] ng·h/mL

  9. Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)

    Tmax,ss will be derived from the plasma concentration-time profile at steady state during multiple ascending dosing (Day 1-7)

    [Unit of Measure] Hour (h)

  10. Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)

    Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)

    The terminal elimination half-life at steady state will be estimated from the terminal phase of the plasma concentration-time curve during multiple ascending dosing (Day 1-7)

    [Unit of Measure] Hour (h)

  11. Pharmacodynamic Parameters: Gastric pH monitoring (SAD)

    Time frame: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour

    Median pH value at specific time points and intervals

    : Median pH value over 4, 12, 24 hours from the time of administration

  12. Pharmacodynamic Parameters: Gastric pH monitoring (MAD)

    Time frame: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour, Day7 0hour to 24hour

    Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration

  13. Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)

    Time frame: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose

    Maximum plasma gastrin concentration [Unit of measure: ng/L]

  14. Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD)

    Time frame: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose

    Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration [Unit of measure: ng·h/L]

  15. Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)

    Time frame: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour

    Maximum plasma gastrin concentration [Unit of measure: ng/L]

  16. Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD)

    Time frame: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour

    Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration [Unit of measure: ng·h/L]

Study contacts

Contact information is provided by the study sponsor or research team.

YunSeon Kim

CONTACT

[email protected]

82-70-7165-7319

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.