Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 2:35 AM
Study NCT ID:
NCT07183306
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, 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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically significant abnormalities', 'timeFrame': 'From enrollment to the end of treatment at up to 60 weeks', 'description': 'Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.'}, {'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': 'From enrollment to the end of treatment at up to 60 weeks', 'description': 'Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'HT-101: From predose 1 hour to postdose 24 hours HT-102：UP to 36 weeks', 'description': 'Cmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax)', 'timeFrame': 'HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks', 'description': 'Tmax of HT-101 and its metabolite in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC)', 'timeFrame': 'HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks', 'description': 'AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Apparent Terminal Elimination Half-life (T1/2)', 'timeFrame': 'HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks', 'description': 'T1/2 of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Apparent Plasma Clearance (CL/F)', 'timeFrame': 'HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks', 'description': 'CL/F of HT-101 in plasma. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Apparent volume of distribution（Vd/F）', 'timeFrame': 'HT-101：From predose 1 hour to postdose 24 hours. HT-102：UP to 36 weeks', 'description': 'Vd/F of HT-101. First administration: Predose 1 hour; Postdose 0.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours.\n\nChanges in the concentration of and HT-102 in serum, From Day1 until 36 weeks'}, {'measure': 'Maximum Change of Serum HBsAg From Baseline', 'timeFrame': 'Up to 48 weeks', 'description': 'Maximum change of serum HBsAg from Day 1 until 48 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)'}, {'measure': 'Maximum Change of Serum HBV DNA From Baseline', 'timeFrame': 'Up to 48 weeks', 'description': 'Maximum change of serum HBV DNA from Day 1 until 48 weeks (negative values mean reductions from baseline, positive values mean increased from baseline).'}, {'measure': 'Titers of Anti-drug Antibody (ADA) to HT-102', 'timeFrame': 'UP to 36 weeks', 'description': 'ADA analysis for predose 36weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study is A multicenter, open-label, partial multiple-ascending doses phase1b/2 in which participants with chronic hepatitis B virus (HBV) infection will receive HT-101 and/or HT-102 and be assessed for safety, tolerability, Pharmacokinetics, and Pharmacodynamics. Approximately 86 patients with chronic hepatitis B infection were planned to be recruited. Among them, Group A and Group AA received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks. Group B received HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks. Groups C, D, and E received HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks. During the study period, all subjects received nucleoside (acid) analogues (NAs) treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects were eligible for inclusion into the study if they met each of the following criteria:\n\nPatient with CHB\n\nMale subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m\\^2 (inclusive); Chronic HBV infection for \\>/= 6 months; The quantitation level of HBsAg was \\> 100 IU/mL and \\<3000 IU/mL; The quantitation level of HBV DNA \\<LLOQ;\n\n· On Nas therapy for \\>/= 6 months at the time of screening\n\nSubjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;\n\nExclusion Criteria:\n\n* Subjects were excluded from the study if one or more of the following criteria were applicable\n\nParticipants with history of drug allergy or specific allergy; Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems; Participants with history of active pathological bleeding, or bleeding tendency; Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians; Participants with significant liver fibrosis or cirrhosis; Participants with symptoms or a history of hepatic decompensation; Participants with a history or suspected risk of liver cancer;'}, 'identificationModule': {'nctId': 'NCT07183306', 'briefTitle': 'A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou HepaThera Biotech Co., Ltd.'}, 'officialTitle': 'A Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-101 Injection and/or HT-102 Injection in Patients With Chronic Hepatitis B Virus Infection', 'orgStudyIdInfo': {'id': 'HT-101&HT-102-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort A (HT-101)', 'description': 'Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks', 'interventionNames': ['Drug: HT-101']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort AA (HT-101)', 'description': 'Participants will receive received HT-101 injection, administered once every 4 weeks (Q4W), at least for 24 weeks', 'interventionNames': ['Drug: HT-101']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort B （HT-102；HT-101）', 'description': 'Participants will receive HT-102 injection, administered Q4W for 24 weeks and sequential dosed with HT-101 for another 24 weeks', 'interventionNames': ['Drug: HT-101', 'Drug: HT-102']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort C (HT-101 + HT-102)', 'description': 'Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks', 'interventionNames': ['Drug: HT-101', 'Drug: HT-102']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort D (HT-101 + HT-102)', 'description': 'Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks', 'interventionNames': ['Drug: HT-101', 'Drug: HT-102']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Cohort E (HT-101 + HT-102)', 'description': 'Participants will receive HT-101 injection combined with HT-102 injection, administered once every 4 weeks for 24weeks', 'interventionNames': ['Drug: HT-101', 'Drug: HT-102']}], 'interventions': [{'name': 'HT-101', 'type': 'DRUG', 'description': 'HT-101 given by subcutaneous injection.', 'armGroupLabels': ['Experimental: Cohort A (HT-101)', 'Experimental: Cohort AA (HT-101)', 'Experimental: Cohort B （HT-102；HT-101）', 'Experimental: Cohort C (HT-101 + HT-102)', 'Experimental: Cohort D (HT-101 + HT-102)', 'Experimental: Cohort E (HT-101 + HT-102)']}, {'name': 'HT-102', 'type': 'DRUG', 'description': 'HT-102 given by subcutaneous injection.', 'armGroupLabels': ['Experimental: Cohort B （HT-102；HT-101）', 'Experimental: Cohort C (HT-101 + HT-102)', 'Experimental: Cohort D (HT-101 + HT-102)', 'Experimental: Cohort E (HT-101 + HT-102)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Ditan Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '361001', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Xiamen Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510440', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou Eighth People's Hospital, Guangzhou Medical University", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '511518', 'city': 'Qingyuan', 'state': 'Guangdong', 'country': 'China', 'facility': "Qingyuan People's Hospital", 'geoPoint': {'lat': 23.7, 'lon': 113.03333}}, {'zip': '200083', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou HepaThera Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}