HealhtyPhase 1NCT07433556
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers
A Phase 1 study testing IY-828026, IY-828026A and IY-828026B in people with Healhty, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty
- What is being tested?
- IY-828026, IY-828026A and IY-828026B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2026to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Injin Jang, M.D./Ph.D., 82-2-2027-4269, ijjang@snu.ac.kr
About this study
Official title: 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
- Conditions
- Healhty
- Being tested
- IY-828026, Placebo, IY-828026A, IY-828026B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IY-828026Drug
IY-828026
PlaceboDrug
Placebo comparator
IY-828026ADrug
Active comparator
IY-828026BDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| (SAD) IY-828026 10 mg | Experimental | Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator Receives: 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 Receives: 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) Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: IY-828026; Drug: Placebo |
| (MAD) IY-828026A | Active comparator | Participants will receive oral administration of IY-828026A 40mg once daily for 7 days Receives: Drug: IY-828026A |
| (MAD) IY-828026B | Active comparator | Participants will receive oral administration of IY-828026B 50mg once daily for 7 days Receives: Drug: IY-828026B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start23 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shin, Study director, Ilyang Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433556
- Sponsor's protocol ID
- IY-828026-101
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07433556
- Acronym / sponsor ID
- IY-828026-101
- Conditions
- Healhty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| (SAD) IY-828026 10 mg | Experimental | Drug: IY-828026, Drug: PlaceboParitipants will receive single oral administration of IY-828026 10 mg or Placebo comparator |
| (SAD) IY-828026 20 mg | Experimental | Drug: IY-828026, Drug: PlaceboParitipants will receive single oral administration of IY-828026 20 mg or Placebo comparator |
| (SAD) IY-828026 40 mg | Experimental | Drug: IY-828026, Drug: PlaceboPeriod 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) |
| (SAD) IY-828026 80 mg | Experimental | Drug: IY-828026, Drug: PlaceboParitipants will receive single oral administration of IY-828026 80 mg or Placebo comparator |
| (SAD) IY-828026 160 mg | Experimental | Drug: IY-828026, Drug: PlaceboParitipants will receive single oral administration of IY-828026 160 mg or Placebo comparator |
| (MAD) IY-828026 20 mg | Experimental | Drug: IY-828026, Drug: PlaceboParticipants will receive oral administration of IY-828026 20 mg once daily for 7 days |
| (MAD) IY-828026 40 mg | Experimental | Drug: IY-828026, Drug: PlaceboParticipants will receive oral administration of IY-828026 40 mg once daily for 7 days |
| (MAD) IY-828026 80 mg | Experimental | Drug: IY-828026, Drug: PlaceboParticipants will receive oral administration of IY-828026 80 mg once daily for 7 days |
| (MAD) IY-828026A | Active comparator | Drug: IY-828026AParticipants will receive oral administration of IY-828026A 40mg once daily for 7 days |
| (MAD) IY-828026B | Active comparator | Drug: IY-828026BParticipants will receive oral administration of IY-828026B 50mg once daily for 7 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IY-828026IY-828026 | Drug | (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 |
| PlaceboPlacebo comparator | Drug | (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-828026AActive comparator | Drug | (MAD) IY-828026A |
| IY-828026BActive comparator | Drug | (MAD) IY-828026B |
Primary outcome
Number of Participants With Adverse Events
Time frame: 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)
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
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)
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
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)
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
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)
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
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: 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)
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
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)
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
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)
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
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)
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
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)
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
Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration [Unit of measure: ng·h/L]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shin study director
Ilyang Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IY-828026, IY-828026A and IY-828026B in people with Healhty, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YunSeon Kim (82-70-7165-7319, yskim@ilyang.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Approximately Day 9 for SAD and Day 15 for MAD). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.