Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-01 @ 3:02 PM
Study NCT ID:
NCT05217732
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2022-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'double-blind, placebo-controled study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'single ascending doses in part 1 and fasting/nonfasting crossover in part 2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)', 'timeFrame': 'Day 1-day15', 'description': 'safety and tolerability'}], 'secondaryOutcomes': [{'measure': 'Peak plama concentration of ZX-7101A', 'timeFrame': 'Days 1-15', 'description': 'To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A'}, {'measure': 'Area under the plasma concentration of ZX-7101A', 'timeFrame': 'Days 1-15', 'description': 'To evaluate the area under the curve (AUC) plasma-concentration after single oral dose of ZX-7101A'}, {'measure': 'Half-life of ZX-7101A', 'timeFrame': 'Days 1-15', 'description': 'To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A'}, {'measure': 'Concentration of ZX-7101A in urine', 'timeFrame': 'Days 1-15', 'description': 'To evaluate the concentration at a select treatment after single oral dose of ZX-7101A'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues', 'Tolerance', 'Pharmacokinetics', 'Food Effect']}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults age of 18-45 years old\n* BMI in the range of 9\\~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg\n* In the judgement of the investigator, no clinically relevant abnormalities identified by a detailed medical history and full physical examination including BP and pulse rate measurement, or clinical laboratory tests\n* Female subjects of nonchildbearing potential must be not pregnant or lactating. Subjects must consent and comply with the contraception requirement of the study.\n* Able to understand the risks involved in the study, and provide written informed consent before the first study-specific procedure\n* Able to understand and comply with the study procedures\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to drug or food\n* History of clinically significant abnormalities such as metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders; or in the judgement of the investigator, any medical abnormality that may be a concern to participate the study.\n* Tympanic temperature \\>37.5℃, Pulse \\>100bmp or \\<50bmp, Systolic blood pressure ≥140mHg or ≤90mHg, or Diastolic blood pressure ≥90mHg or\\<50mHg\n* Clinically relevant out-of-range baseline of total white cells or absolute neutrophil count\n* Total bilirubin \\>1.5x ULN, AST \\>1.5 ULN or ALT \\>1.5ULN\n* Estimated glomerular filtration rate (eGFR) \\<90 mL/min/1.73 m2\n* QTc interval \\> 450ms （ Fridericia's correction ， QTcF=QT/(RR\\^0.33) ）, QRS\\>120ms\n* Acute respiratory tract infection within 2 weeks\n* Any condition possibly affecting drug absorption, e.g. gastrectomy\n* Received treatment of any prescription drug or alternative medicine within 4 weeks before first dosing or any nonprescription drug within 2 weeks or 5x half-life, whichever is longer\n* Regular alcohol consumption \\>14units/week I the past 6 months or positive in alcohol breath test\n* Use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day within 3 months\n* Unwilling or unable to restrict the intake of caffeine or alcohol within 72 hours before dosing or during the in-patient observation period\n* Use or intake of any known liver enzyme inducer or inhibitor within 14 days\n* History of drug abuse or positive urine drug test\n* Positive test for Hepatitis C antibody (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening\n* Accumulative blood donation \\>400ml within 3 months or \\>200ml within 4 weeks or planning to donate during the study\n* Pregnancy or lactating at screening\n* Having difficulty of drawing blood from vein\n* Treatment with an investigational drug or procedure within 3 months\n* Received vaccination within 3 months or plan to be received vaccine during the study\n* Received any surgical procedure within 3 months at screening\n* Any other reason that, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason."}, 'identificationModule': {'nctId': 'NCT05217732', 'briefTitle': 'Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Zenshine Pharmaceuticals'}, 'officialTitle': 'Randomized, Double-blind and Placebo-controled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of ZX-7101A and Its Food Effect in China Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'ZX-7101A-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose of ZX-7101A treatment A', 'description': 'Administrated as a single oral dose in healthy subjects', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose of ZX-7101A treatment B', 'description': 'Administrated as a single oral dose in healthy subjects', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose of ZX-7101A treatment C', 'description': 'Administrated as a single oral dose in healthy subjects', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose of ZX-7101A treatment D', 'description': 'Administrated as a single oral dose in healthy subjects', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Single dose of ZX-7101A treatment E', 'description': 'Administrated as a single oral dose in healthy subjects', 'interventionNames': ['Drug: ZX-7101A', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ZX-7101A food effect', 'description': 'Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state.', 'interventionNames': ['Drug: ZX-7101A']}], 'interventions': [{'name': 'ZX-7101A', 'type': 'DRUG', 'description': 'tablet', 'armGroupLabels': ['Single dose of ZX-7101A treatment A', 'Single dose of ZX-7101A treatment B', 'Single dose of ZX-7101A treatment C', 'Single dose of ZX-7101A treatment D', 'Single dose of ZX-7101A treatment E', 'ZX-7101A food effect']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['Single dose of ZX-7101A treatment A', 'Single dose of ZX-7101A treatment B', 'Single dose of ZX-7101A treatment C', 'Single dose of ZX-7101A treatment D', 'Single dose of ZX-7101A treatment E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University affiliated Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoli Qin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zenshine Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Zenshine Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}