Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT07200193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of single and multiple doses of CRMA-1001', 'timeFrame': '6 months', 'description': 'Incidence and severity of treatment-emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Long-term safety of single and multiple doses of CRMA-1001', 'timeFrame': '60 Months', 'description': 'Incidence and severity of treatment emergent adverse events'}, {'measure': 'Pharmacokinetics of CRMA-1001 components (Cmax)', 'timeFrame': '6 Months', 'description': 'Maximum concentration (Cmax) in plasma'}, {'measure': 'Pharmacokinetics of CRMA-1001 components (Tmax)', 'timeFrame': '6 Months', 'description': 'Time of maximum concentration (Tmax) in plasma'}, {'measure': 'Pharmacokinetics of CRMA-1001 components (terminal clearance rate)', 'timeFrame': '6 Months', 'description': 'Clearance rate in terminal clearance phase (CL) in plasma'}, {'measure': 'Pharmacokinetics of CRMA-1001 components (Vd)', 'timeFrame': '6 Months', 'description': 'Volume of distribution (Vd) in plasma'}, {'measure': 'To evaluate the immunogenicity of CRMA-1001', 'timeFrame': '6 Months', 'description': 'Incidence and characterization of anti-drug antibodies'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)', 'timeFrame': '6 Months', 'description': 'Change from baseline in HBsAg'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)', 'timeFrame': '6 Months', 'description': 'Change from baseline in anti-HBs antibody titier'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)', 'timeFrame': '6 Months', 'description': 'Change from baseline in HBV DNA'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)', 'timeFrame': '6 Months', 'description': 'Change from baseline in HBeAg'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)', 'timeFrame': '6 Months', 'description': 'Change from baseline in anti-HBe antibody titer'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg)', 'timeFrame': '60 Months', 'description': 'Change from baseline in HBsAg'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs)', 'timeFrame': '60 Months', 'description': 'Change from baseline in anti-HBs antibody titer'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA)', 'timeFrame': '60 Months', 'description': 'Change from baseline in HBV DNA'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg)', 'timeFrame': '60 Months', 'description': 'Change from baseline in HBeAg'}, {'measure': 'To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe)', 'timeFrame': '60 Months', 'description': 'Change from baseline in anti-HBe antibody titer'}, {'measure': 'To evaluate the rate of antiviral therapy discontinuation after treatment with CRMA-1001', 'timeFrame': '60 Months', 'description': 'Proportion of participants able to discontinue antiviral therapy'}, {'measure': 'To evaluate the effect of CRMA-1001 on the incidence of functional cure', 'timeFrame': '60 Months', 'description': 'Incidence of functional cure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CHB', 'Chronic hepatitis B', 'Chronic HBV', 'Chronic Hep B', 'Chronic hepatitis', 'HBV'], 'conditions': ['Chronic Hepaititis B']}, 'descriptionModule': {'briefSummary': 'This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/Female, weight 45-150 kg, age 18-64, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On oral antiviral therapy\n* ALT and AST \\<= 1.5 x ULN\n* Total bilirubin \\<= ULN\n\nExclusion Criteria:\n\n* Significant hepatic fibrosis or cirrhosis\n* Current or prior liver disease other than HBV\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT07200193', 'briefTitle': 'A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'nChroma Bio'}, 'officialTitle': 'A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'CRMA-1001-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRMA-1001 Part A, SAD', 'description': 'Single ascending dose arm', 'interventionNames': ['Genetic: CRMA-1001']}, {'type': 'EXPERIMENTAL', 'label': 'CRMA-1001 Part A, MAD', 'description': 'Multiple ascending dose arm', 'interventionNames': ['Genetic: CRMA-1001']}, {'type': 'EXPERIMENTAL', 'label': 'CRMA-1001 Part B', 'description': 'Dose expansion', 'interventionNames': ['Genetic: CRMA-1001']}], 'interventions': [{'name': 'CRMA-1001', 'type': 'GENETIC', 'description': 'Epigenetic gene silencing therapy delivered by intravenous (IV) infusion', 'armGroupLabels': ['CRMA-1001 Part A, MAD', 'CRMA-1001 Part A, SAD', 'CRMA-1001 Part B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nChroma Bio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}