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

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

Study Overview

• Status: Recruiting
• Conditions: Healhty
• Intervention / Treatment: Drug: Placebo; Drug: IY-828026; Drug: IY-828026A; Drug: IY-828026B

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: YunSeon Kim; Phone Number: 82-70-7165-7319; Email: yskim@ilyang.co.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: Injin Jang, M.D./Ph.D.; Phone Number: 82-2-2027-4269; Email: ijjang@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (SAD) IY-828026 10 mg; Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (SAD) IY-828026 20 mg; Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (SAD) IY-828026 40 mg; Period 1: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fast) Period 2: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fed)	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (SAD) IY-828026 80 mg; Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (SAD) IY-828026 160 mg; Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (MAD) IY-828026 20 mg; Participants will receive oral administration of IY-828026 20 mg once daily for 7 days	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (MAD) IY-828026 40 mg; Participants will receive oral administration of IY-828026 40 mg once daily for 7 days	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Experimental: (MAD) IY-828026 80 mg; Participants will receive oral administration of IY-828026 80 mg once daily for 7 days	Drug: Placebo; Placebo comparator; Drug: IY-828026; IY-828026
Active Comparator: (MAD) IY-828026A; Participants will receive oral administration of IY-828026A 40mg once daily for 7 days	Drug: IY-828026A; Active comparator
Active Comparator: (MAD) IY-828026B; Participants will receive oral administration of IY-828026B 50mg once daily for 7 days	Drug: IY-828026B; Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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	Approximately Day 9 for SAD and Day 15 for MAD
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)	Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026 [Unit of Measure] ng/mL	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
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)	AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026 [Unit of Measure] ng·h/mL	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
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)	AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026 [Unit of Measure] ng·h/mL	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
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)	Tmax will be derived from the plasma concentration-time profile following a single ascending dose of IY-828026	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
Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)	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)	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
Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)	Cmax,ss will be measured at steady state during multiple ascending dosing (Day 1-7). [Unit of Measure] ng/mL	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)
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)	AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7) [Unit of Measure] ng·h/mL	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)
Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)	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)	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)
Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)	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)	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)
Pharmacodynamic Parameters: Gastric pH monitoring (SAD)	Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration	Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour
Pharmacodynamic Parameters: Gastric pH monitoring (MAD)	Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration	Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour, Day7 0hour to 24hour
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)	Maximum plasma gastrin concentration [Unit of measure: ng/L]	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
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD)	Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration [Unit of measure: ng·h/L]	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
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)	Maximum plasma gastrin concentration [Unit of measure: ng/L]	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
Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD)	Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration [Unit of measure: ng·h/L]	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

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Study Director: Shin, Ilyang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IY-828026-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No