Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT06671093
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-10-28', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as assessed by treatment emergent adverse events', 'timeFrame': '20 weeks', 'description': 'Number of participants with treatment-related adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Long-term safety', 'timeFrame': '104 weeks', 'description': 'Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)'}, {'measure': 'Tune-401 Pharmacokinetics (Cmax)', 'timeFrame': '8 weeks', 'description': 'Maximum concentration (Cmax)'}, {'measure': 'Tune-401 Pharmacokinetics (Tmax)', 'timeFrame': '8 weeks', 'description': 'Time it takes to reach Cmax (Tmax)'}, {'measure': 'Tune-401 Pharmacokinetics (AUC)', 'timeFrame': '8 weeks', 'description': 'Extrapolated area under the concentration-time curve (AUC-infinity)'}, {'measure': 'Tune-401 Pharmacokinetics (CL)', 'timeFrame': '8 weeks', 'description': 'Clearance (CL)'}, {'measure': 'Tune-401 Pharmacokinetics (half-life)', 'timeFrame': '8 weeks', 'description': 'Terminal half-life (t½)'}, {'measure': 'Tune-401 Pharmacokinetics (Vd)', 'timeFrame': '8 weeks', 'description': 'Volume of distribution (Vd)'}, {'measure': 'Tune-401 Pharmacodynamics', 'timeFrame': '104 weeks', 'description': 'Changes from baseline in HBsAg'}, {'measure': 'Tune-401 Immunogenicity', 'timeFrame': '104 weeks', 'description': 'Development of anti-Tune-401 antibodies'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tune-401', 'Tune-401-001', 'CHB'], 'conditions': ['Chronic Hep B', 'Chronic Hepatitis b', 'Chronic Hepatitis', 'HBV']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.', 'detailedDescription': 'This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* M/F, BMI ≥ 18.5 kg/m² at screening, age 18-75, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On nucleos(t)ide analogue\n* HBeAg-negative or positive\n\nExclusion Criteria:\n\n* ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN\n* Participants with any evidence or history of liver disease of non-HBV etiology\n* Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06671093', 'briefTitle': 'Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tune Therapeutics, Inc.'}, 'officialTitle': 'Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection', 'orgStudyIdInfo': {'id': 'Tune-401-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tune-401 Part I : Single Ascending Dose', 'description': 'Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration', 'interventionNames': ['Genetic: Tune-401']}, {'type': 'EXPERIMENTAL', 'label': 'Tune-401 Part II :Single/Finite Multiple Dose', 'description': 'Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration', 'interventionNames': ['Genetic: Tune-401']}], 'interventions': [{'name': 'Tune-401', 'type': 'GENETIC', 'description': 'Epigenetic gene silencing therapy', 'armGroupLabels': ['Tune-401 Part I : Single Ascending Dose', 'Tune-401 Part II :Single/Finite Multiple Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Man Fung Yuen', 'role': 'CONTACT'}, {'name': 'Man Fung Yuen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital, University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': 'MD2025', 'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'contacts': [{'name': 'Alina Jucov', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '1010', 'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'New Zealand Clinical Research', 'role': 'CONTACT', 'email': 'startup@nzcr.co.nz', 'phone': '+64 9 373 3474'}], 'facility': 'New Zealand Clinical Research', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'centralContacts': [{'name': 'Tune Therapeutics, Inc.', 'role': 'CONTACT', 'email': 'clinical.operations@tunetx.com', 'phone': '855 755 8863'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tune Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}