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

NCT07433556 | Recruiting Phase 1

• 1 other identifier: IY-828026-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Healhty

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (10)

(SAD) IY-828026 10 mg

EXPERIMENTAL

Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator

Drug: IY-828026; Drug: Placebo

(SAD) IY-828026 20 mg

EXPERIMENTAL

Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator

Drug: IY-828026; Drug: Placebo

(SAD) IY-828026 40 mg

EXPERIMENTAL

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: IY-828026; Drug: Placebo

(SAD) IY-828026 80 mg

EXPERIMENTAL

Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator

Drug: IY-828026; Drug: Placebo

(SAD) IY-828026 160 mg

EXPERIMENTAL

Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator

Drug: IY-828026; Drug: Placebo

(MAD) IY-828026 20 mg

EXPERIMENTAL

Participants will receive oral administration of IY-828026 20 mg once daily for 7 days

Drug: IY-828026; Drug: Placebo

(MAD) IY-828026 40 mg

EXPERIMENTAL

Participants will receive oral administration of IY-828026 40 mg once daily for 7 days

Drug: IY-828026; Drug: Placebo

(MAD) IY-828026 80 mg

EXPERIMENTAL

Participants will receive oral administration of IY-828026 80 mg once daily for 7 days

Drug: IY-828026; Drug: Placebo

(MAD) IY-828026A

ACTIVE COMPARATOR

Participants will receive oral administration of IY-828026A 40mg once daily for 7 days

Drug: IY-828026A

(MAD) IY-828026B

ACTIVE COMPARATOR

Participants will receive oral administration of IY-828026B 50mg once daily for 7 days

Drug: IY-828026B

Interventions

IY-828026 DRUG

IY-828026

(MAD) IY-828026 20 mg; (MAD) IY-828026 40 mg; (MAD) IY-828026 80 mg; (SAD) IY-828026 10 mg; (SAD) IY-828026 160 mg; (SAD) IY-828026 20 mg; (SAD) IY-828026 40 mg; (SAD) IY-828026 80 mg

Placebo DRUG

Placebo comparator

(MAD) IY-828026 20 mg; (MAD) IY-828026 40 mg; (MAD) IY-828026 80 mg; (SAD) IY-828026 10 mg; (SAD) IY-828026 160 mg; (SAD) IY-828026 20 mg; (SAD) IY-828026 40 mg; (SAD) IY-828026 80 mg

IY-828026B DRUG

Active comparator

(MAD) IY-828026B

IY-828026A DRUG

Active comparator

(MAD) IY-828026A

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Shin

  Ilyang Pharmaceutical

  STUDY DIRECTOR

Central Study Contacts

YunSeon Kim

CONTACT

82-70-7165-7319; yskim@ilyang.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 25, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

KR (1)