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

NCT07433556 · tracked via the Priya Life Science South Korea tracker

Sponsor

Il-Yang Pharm. Co., Ltd

Phase

Phase 1

Started

2026-03-23

Last updated

2026-03-27

Condition(s) studied

Healhty

Investigational drug(s) / intervention(s)

IY-828026PlaceboIY-828026AIY-828026B

IY-828026: IY-828026

Placebo: Placebo comparator

IY-828026A: Active comparator

IY-828026B: Active comparator

Study 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

Sex

ALL

Min age

19 Years

Max age

50 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Number of Participants With Adverse Events — 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
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD) — 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
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD) — 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
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD) — 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
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD) — 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
Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD) — 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)
Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD) — 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
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD) — 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
Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD) — 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)
Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD) — 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)
Pharmacodynamic Parameters: Gastric pH monitoring (SAD) — 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
Pharmacodynamic Parameters: Gastric pH monitoring (MAD) — 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
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD) — 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 \[Unit of measure: ng/L\]
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD) — 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 \[Unit of measure: ng·h/L\]
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD) — 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 \[Unit of measure: ng/L\]
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD) — 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 \[Unit of measure: ng·h/L\]

Trial sites (1)

Facility	City	Region	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07433556 on ClinicalTrials.gov ↗ ← All trials in South Korea