[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644760":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":34,"responsibleParty":45,"collaborators":34,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":34,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":34,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":34,"overallStatus":66,"whyStopped":34,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":34},{"fullName":5,"class":6},"Grand Theravac Life Sciences (Nanjing) Co., Ltd.","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjuvant Group","OTHER","Participants receive adjuvant alone",[13],"Other: Adjuvant",{"label":15,"type":16,"description":17,"interventionNames":18},"TVAX-028 low-dose group","EXPERIMENTAL","Participants receive low-dose TVAX-028 with adjuvant",[19],"Drug: TVAX-028",{"label":21,"type":16,"description":22,"interventionNames":23},"TVAX-028 medium-dose group","Participants receive medium-dose TVAX-028 with adjuvant",[19],{"label":25,"type":16,"description":26,"interventionNames":27},"TVAX-028 high-dose group","Participants receive high-dose TVAX-028 with adjuvant",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","TVAX-028","TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.",[25,15,21],null,{"type":10,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Adjuvant","Adjuvant will be administered alone in the adjuvant group",[9],[40],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Lina Chen","CONTACT","086+19921306230","chenlina@theravac.cn",{"type":46,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100644760","phase-1-clinical-trial-to-evaluate-the-safety-tolerability-and-pharmacokinetic-profile-of-tvax-028-in-the-treatment-of-chronic-hepatitis-b-100644760",false,"NCT07673068","Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.\n* 2\\. Male or female, aged 18 to 65 years.\n* 3\\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.\n* 4\\. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028.\n* 5\\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.\n* 6\\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028.\n* 7\\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.\n* 8\\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.\n\nExclusion Criteria:\n\n* 1\\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results\n* 2\\. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.\n* 3\\. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.\n* 4\\. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.\n* 5\\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 6\\. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids.\n* 7\\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.\n* 8\\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.\n* 9\\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.\n* 10\\. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol.\n* 11\\. Has previously received organ transplantation.\n* 12\\. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products.\n* 13\\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.\n* 14\\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.\n* 15\\. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products.\n* 16\\. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 17\\. Is pregnant or breastfeeding.\n* 18\\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.","ALL","18 Years","65 Years",{"count":58,"type":59},32,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection",[65],"HBV Infection","NOT_YET_RECRUITING","2026-06-24",{"date":69,"type":70},"2026-06-29","ACTUAL",{"date":72,"type":59},"2026-05-31",{"date":74,"type":59},"2027-05-31",{"name":5,"class":6}]