Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT05875493
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Food Effect Study of JAB-21822 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is an open-label,randomized, 2-cycle,2-period crossover,food effect study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-04-23', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under plasma concentration (AUC) 0 to∞', 'timeFrame': '31days', 'description': 'Area under the plasma concentration time curve of JAB-21822'}, {'measure': 'Area under plasma concentration (AUC) 0 to t', 'timeFrame': '31days', 'description': 'Area under the plasma concentration time curve of JAB-21822'}, {'measure': 'Plasma concentration ( Cmax)', 'timeFrame': '31days', 'description': 'Highest observed plasma concentration of JAB-21822'}], 'secondaryOutcomes': [{'measure': 'Time to achieve Cmax (Tmax)', 'timeFrame': '31days', 'description': 'Time of highest observed plasma concentration of JAB-21822'}, {'measure': 'Elimination rate constant (λz)', 'timeFrame': '31days', 'description': 'Elimination rate constant based on the terminal phase of unchanged form of JAB-21822'}, {'measure': 'Concentration half-life (T1/2)', 'timeFrame': '31days', 'description': 'Elimination half-life of unchanged form of JAB-21822'}, {'measure': 'Absorption lag-time (Tlag)', 'timeFrame': '31days', 'description': 'Elimination lag-time of JAB-21822'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': '31days', 'description': 'Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': '31days', 'description': 'Apparent total body clearance of unchanged form of JAB-21822'}, {'measure': 'Number of participants with adverse events (AEs) and serious adverse events(SAEs)', 'timeFrame': '31days', 'description': 'Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0'}, {'measure': 'Number of subjects with abnormal lab parameters', 'timeFrame': '31days', 'description': 'Abnormal values of lab parameters'}, {'measure': 'Number of subjects with abnormal electrocardiogram (12-lead ECG)', 'timeFrame': '31days', 'description': 'Prolongation of the QTc interval'}, {'measure': 'Number of subjects with abnormal systolic and diastolic blood pressure', 'timeFrame': '31days', 'description': 'Abnormal values in systolic and diastolic blood pressure'}, {'measure': 'Number of subjects with abnormal pulse rate', 'timeFrame': '31days', 'description': 'Abnormal values in pulse rate'}, {'measure': 'Number of subjects with abnormal respiratory rate', 'timeFrame': '31days', 'description': 'Abnormal values in respiratory rate'}, {'measure': 'Number of subjects with abnormal body temperature', 'timeFrame': '31days', 'description': 'Abnormal values of body temperature'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Effect in Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal', 'detailedDescription': 'This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female , between 18 and 45 years of age\n* Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive\n* No clinically significant abnormalities identified in the judgement of investigator at screening\n* Written informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n* History of clinically significant disease or disorder\n* History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases\n* History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug\n* COVID-19 positive at screening or baseline\n* Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food\n* Received surgical procedure within 3 months at screening\n* Blood donation within the 3 months or planing to donate during the study\n* Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening\n* History of drug abuse or positive urine drug test\n* Received the vaccine within 3 months at screening or planning to receive during the study\n* Overtake of achole,tea and coffee prior to first dosing and unable to control during the study\n* Special dietary requirements or unable to control during the study\n* HIV, HBV, HCV, and syphilis positive\n* Pregnant or breast-feeding women or positive of blood pregnancy test\n* Subjects who are considered to be unacceptable in this study under the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT05875493', 'briefTitle': 'A Food Effect Study of JAB-21822 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allist Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'JAB-21822-1009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-JAB-21822', 'description': 'Dosing in the fasted state followed by fed dosing', 'interventionNames': ['Drug: JAB-21822']}, {'type': 'EXPERIMENTAL', 'label': 'B-JAB-21822', 'description': 'Dosing in the fed state followed by fasted dosing', 'interventionNames': ['Drug: JAB-21822']}], 'interventions': [{'name': 'JAB-21822', 'type': 'DRUG', 'description': '2 discrete single doses', 'armGroupLabels': ['A-JAB-21822']}, {'name': 'JAB-21822', 'type': 'DRUG', 'description': '2 discrete single doses', 'armGroupLabels': ['B-JAB-21822']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing GoBroad Boren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'He Qing B.Pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Gaobo Boren Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allist Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}