Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:49 PM
Study NCT ID:
NCT07433556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Approximately Day 9 for SAD and Day 15 for MAD', 'description': '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.\n\nEvents will be coded using MedDRA System Organ Class and Preferred Term.\n\n\\[Unit of Measure\\] Participants'}, {'measure': 'Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)', 'timeFrame': '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', 'description': 'Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026\n\n\\[Unit of Measure\\] ng/mL'}, {'measure': 'Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)', 'timeFrame': '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', 'description': 'AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026\n\n\\[Unit of Measure\\] ng·h/mL'}, {'measure': 'Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)', 'timeFrame': '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', 'description': 'AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026\n\n\\[Unit of Measure\\] ng·h/mL'}, {'measure': 'Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)', 'timeFrame': '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', 'description': 'Tmax will be derived from the plasma concentration-time profile following a single ascending dose of IY-828026'}, {'measure': 'Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)', 'timeFrame': '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', 'description': 'Terminal elimination half-life will be estimated from the terminal phase of the concentration-time curve following a single ascending dose of IY-828026\n\n\\[Unit of Measure\\] Hour (h)'}, {'measure': 'Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)', 'timeFrame': '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)', 'description': 'Cmax,ss will be measured at steady state during multiple ascending dosing (Day 1-7).\n\n\\[Unit of Measure\\] ng/mL'}, {'measure': 'Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)', 'timeFrame': '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)', 'description': 'AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7)\n\n\\[Unit of Measure\\] ng·h/mL'}, {'measure': 'Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)', 'timeFrame': '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)', 'description': 'Tmax,ss will be derived from the plasma concentration-time profile at steady state during multiple ascending dosing (Day 1-7)\n\n\\[Unit of Measure\\] Hour (h)'}, {'measure': 'Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)', 'timeFrame': '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)', 'description': '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)\n\n\\[Unit of Measure\\] Hour (h)'}, {'measure': 'Pharmacodynamic Parameters: Gastric pH monitoring (SAD)', 'timeFrame': 'Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour', 'description': 'Median pH value at specific time points and intervals\n\n: Median pH value over 4, 12, 24 hours from the time of administration'}, {'measure': 'Pharmacodynamic Parameters: Gastric pH monitoring (MAD)', 'timeFrame': 'Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour, Day7 0hour to 24hour', 'description': 'Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration'}, {'measure': 'Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)', 'timeFrame': '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', 'description': 'Maximum plasma gastrin concentration \\[Unit of measure: ng/L\\]'}, {'measure': 'Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD)', 'timeFrame': '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', 'description': 'Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \\[Unit of measure: ng·h/L\\]'}, {'measure': 'Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)', 'timeFrame': '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', 'description': 'Maximum plasma gastrin concentration \\[Unit of measure: ng/L\\]'}, {'measure': 'Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD)', 'timeFrame': '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', 'description': 'Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \\[Unit of measure: ng·h/L\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healhty']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteers aged ≥ 19 and ≤ 50 years at screening\n* 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\n* Volunteers who were fully informed of and completely understood this study, voluntarily agreed to participate, and provided written consent to comply with the precautions\n\nExclusion Criteria:\n\n* 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\n* H. pylori eradication treatment within 6 months or positive result for H. pylori at screening\n* Hypersensitivity or history of clinically significant hypersensitivity to PPIs, P-CABs, and other drugs (aspirin, antibiotics, etc.)\n* A positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus \\[HIV\\] tests, or syphilis tests)\n* History of drug abuse or positive results for drug abuse in the urine drug screen'}, 'identificationModule': {'nctId': 'NCT07433556', 'briefTitle': 'Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Il-Yang Pharm. Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IY-828026-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(SAD) IY-828026 10 mg', 'description': 'Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(SAD) IY-828026 20 mg', 'description': 'Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(SAD) IY-828026 40 mg', 'description': '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)', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(SAD) IY-828026 80 mg', 'description': 'Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(SAD) IY-828026 160 mg', 'description': 'Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(MAD) IY-828026 20 mg', 'description': 'Participants will receive oral administration of IY-828026 20 mg once daily for 7 days', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(MAD) IY-828026 40 mg', 'description': 'Participants will receive oral administration of IY-828026 40 mg once daily for 7 days', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '(MAD) IY-828026 80 mg', 'description': 'Participants will receive oral administration of IY-828026 80 mg once daily for 7 days', 'interventionNames': ['Drug: IY-828026', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(MAD) IY-828026A', 'description': 'Participants will receive oral administration of IY-828026A 40mg once daily for 7 days', 'interventionNames': ['Drug: IY-828026A']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(MAD) IY-828026B', 'description': 'Participants will receive oral administration of IY-828026B 50mg once daily for 7 days', 'interventionNames': ['Drug: IY-828026B']}], 'interventions': [{'name': 'IY-828026', 'type': 'DRUG', 'description': 'IY-828026', 'armGroupLabels': ['(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']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['(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']}, {'name': 'IY-828026A', 'type': 'DRUG', 'description': 'Active comparator', 'armGroupLabels': ['(MAD) IY-828026A']}, {'name': 'IY-828026B', 'type': 'DRUG', 'description': 'Active comparator', 'armGroupLabels': ['(MAD) IY-828026B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Injin Jang, M.D./Ph.D.', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr', 'phone': '82-2-2027-4269'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'YunSeon Kim', 'role': 'CONTACT', 'email': 'yskim@ilyang.co.kr', 'phone': '82-70-7165-7319'}], 'overallOfficials': [{'name': 'Shin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ilyang Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Il-Yang Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}