Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-03 @ 3:57 AM
Study NCT ID:
NCT05022693
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label, single dose, PK study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK Profile of liquid formulation of BIO89-100', 'timeFrame': '22 days', 'description': 'Determine maximum observed serum drug concentration (Cmax)'}, {'measure': 'PK Profile of liquid formulation of BIO89-100', 'timeFrame': '22 days', 'description': 'Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t)'}], 'secondaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of the BIO89-100 liquid formulation', 'timeFrame': '22 days', 'description': 'Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)\n\nNumber of subjects who discontinued due to AEs and due to related AEs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NASH - Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age 21 to 65\n* Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.\n* Model for End-Stage Liver Disease (MELD) score \\< 12.\n* Child-Turcotte-Pugh (CTP) score \\< 7 (Class A).\n* Fibrosis stage F4 by FibroScan.\n\nKey Exclusion Criteria:\n\n* History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.\n* Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.\n* known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.\n* Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.'}, 'identificationModule': {'nctId': 'NCT05022693', 'briefTitle': 'PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': '89bio, Inc.'}, 'officialTitle': 'An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis', 'orgStudyIdInfo': {'id': 'BIO89-100-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIO89-100 30 mg, Open Lable, Single Dose', 'interventionNames': ['Drug: BIO89-100']}], 'interventions': [{'name': 'BIO89-100', 'type': 'DRUG', 'description': 'Subcutaneous Injections', 'armGroupLabels': ['BIO89-100 30 mg, Open Lable, Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '89bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}