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
Il-Yang Pharm. Co., Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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