A Phase 1 interventional study of IY-828026 and Placebo in Healhty, sponsored by Il-Yang Pharm. Co., Ltd.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Il-Yang Pharm. Co., Ltd. · Phase 1, Interventional, and Treatment
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
Exclusion Criteria:
Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator
Drug: IY-828026 · Drug: Placebo
Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator
Drug: IY-828026 · Drug: Placebo
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
Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator
Drug: IY-828026 · Drug: Placebo
Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator
Drug: IY-828026 · Drug: Placebo
Participants will receive oral administration of IY-828026 20 mg once daily for 7 days
Drug: IY-828026 · Drug: Placebo
Participants will receive oral administration of IY-828026 40 mg once daily for 7 days
Drug: IY-828026 · Drug: Placebo
Participants will receive oral administration of IY-828026 80 mg once daily for 7 days
Drug: IY-828026 · Drug: Placebo
Participants will receive oral administration of IY-828026A 40mg once daily for 7 days
Drug: IY-828026A
Participants will receive oral administration of IY-828026B 50mg once daily for 7 days
Drug: IY-828026B
IY-828026
Placebo comparator
Active comparator
Active comparator
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
Time frame: 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
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
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
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
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
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
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
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
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)
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
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
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)
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
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)
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)
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)
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)
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)
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
Time frame: 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
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
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)
Maximum plasma gastrin concentration \[Unit of measure: ng/L\]
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
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 \[Unit of measure: ng·h/L\]
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
Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)
Maximum plasma gastrin concentration \[Unit of measure: ng/L\]
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
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 \[Unit of measure: ng·h/L\]
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
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Il-Yang Pharm. Co., Ltd.