Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT05680233
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2022-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
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', 'maskingDescription': 'All subjects will be blinded to IP dose/level in Phase 1a; subjects, Investigator and site staff (excluding unblinded pharmacy staff) will be blinded to IP/placebo in Phase 1b.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single ascending dose (SAD) sequential group study of a sc dose of OA-235i in five (5) planned dose cohorts with 3 subjects/cohort administering a bolus injection at escalating dose levels from 4 to 40 mg. One (1) planned multiple dose (MD), randomized, placebo-controlled expansion cohort with 9 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '30 Days', 'description': 'Number of participants with treatment-emergent with adverse events (incidence and severity)'}], 'secondaryOutcomes': [{'measure': 'To characterize the OA-235i Pharmacokinetics (PK) by Cmax', 'timeFrame': '8 Days', 'description': 'OA-235i PK by peak plasma concentration (Cmax)'}, {'measure': 'To characterize the OA-235i Pharmacokinetics (PK) by t1/2', 'timeFrame': '8 Days', 'description': 'OA-235i PK by the terminal elimination half-life (t1/2)'}, {'measure': 'To characterize the OA-235i Pharmacokinetics (PK) by Tmax', 'timeFrame': '8 Days', 'description': 'OA-235i PK by time to peak plasma concentration (Tmax)'}, {'measure': 'To characterize the OA-235i Pharmacokinetics (PK) by AUC', 'timeFrame': '8 Days', 'description': 'OA-235i PK by area under the plasma concentration versus time curve (AUC)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Steatohepatitis', 'Nonalcoholic Fatty Liver']}, 'descriptionModule': {'briefSummary': 'This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.', 'detailedDescription': 'The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (SAD) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. This dose-escalating strategy will test the safety of OA-235i when given as a single subcutaneous dosage using up to five successive cohorts. Each cohort will have three non-randomized participants receiving the active medication. One (1) planned multiple dose (MD) randomized, placebo-controlled expansion cohort with 9 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.\n2. Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following:\n\n 1. Histologically with liver biopsy within 2 years prior to Screening (documentation with pathology report); or\n 2. Radiologically with ≥5% steatosis measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), or controlled attenuation parameter (CAP) \\>238 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound ; or\n 3. Clinically with a diagnosis of Metabolic Syndrome (MetS) reflecting the presence of at least 3 of 5 factors/criteria (ie, abdominal obesity, elevated triglycerides, reduced HDL-C, elevated blood pressure, and/or elevated fasting glucose \\[IFG or type 2 diabetes mellitus\\]) as defined by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) \\[Grundy 2005\\]; and fatty liver on imaging within 1 year prior to Screening.\n\nKey Exclusion Criteria:\n\n1. History or presence of cirrhosis as assessed by Investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory).\n2. Clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.).\n3. History or presence of other concomitant liver disease (eg, hepatitis B \\& C, alcoholic liver disease, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin (A1AT) deficiency, bile duct obstruction, liver primary or metastatic cancer, drug-induced liver disease."}, 'identificationModule': {'nctId': 'NCT05680233', 'briefTitle': 'Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oasis Pharmaceuticals, LLC'}, 'officialTitle': 'A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OA-235i, a PAR2 Inhibitor, in Adults With Nonalcoholic Steatohepatitis', 'orgStudyIdInfo': {'id': 'OAS-235i-101'}, 'secondaryIdInfos': [{'id': '5R44DK101240', 'link': 'https://reporter.nih.gov/quickSearch/5R44DK101240', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OA-235i (4-40 mg)', 'description': 'Single ascending dose (SAD): OA-235i (4-40 mg) administered subcutaneously (SC) once to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis.\n\nMultiple dose (MD): OA-235i (dose level to be determined from SAD) or placebo administered subcutaneously (SC) once daily for 7 days to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis.', 'interventionNames': ['Drug: OA-235i (4 mg)', 'Drug: OA-235i (8 mg)', 'Drug: OA-235i (16 mg)', 'Drug: OA-235i (30 mg)', 'Drug: OA-235i (40 mg)', 'Drug: OA-235i or placebo']}], 'interventions': [{'name': 'OA-235i (4 mg)', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor'], 'description': '3 participants will receive 4 mg as a single subcutaneous dose', 'armGroupLabels': ['OA-235i (4-40 mg)']}, {'name': 'OA-235i (8 mg)', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor'], 'description': '3 participants will receive 8 mg as a single subcutaneous dose', 'armGroupLabels': ['OA-235i (4-40 mg)']}, {'name': 'OA-235i (16 mg)', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor'], 'description': '3 participants will receive 16 mg as a single subcutaneous dose', 'armGroupLabels': ['OA-235i (4-40 mg)']}, {'name': 'OA-235i (30 mg)', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor'], 'description': '3 participants will receive 30 mg as a single subcutaneous dose', 'armGroupLabels': ['OA-235i (4-40 mg)']}, {'name': 'OA-235i (40 mg)', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor'], 'description': '3 participants will receive 40 mg as a single subcutaneous dose', 'armGroupLabels': ['OA-235i (4-40 mg)']}, {'name': 'OA-235i or placebo', 'type': 'DRUG', 'otherNames': ['PAR2 inhibitor', 'placebo'], 'description': '9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days', 'armGroupLabels': ['OA-235i (4-40 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Athan Kuliopulos, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oasis Pharmaceuticals, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oasis Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}