HBV Infection
Conditions
Brief summary
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
Interventions
DRUGTVAX-028
TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.
OTHERAdjuvant
Adjuvant will be administered alone in the adjuvant group
Sponsors
Grand Theravac Life Sciences (Nanjing) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures. * 2\. Male or female, aged 18 to 65 years. * 3\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria. * 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. * 5\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria. * 6\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028. * 7\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment. * 8\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.
Exclusion criteria
* 1\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results * 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. * 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. * 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. * 5\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028. * 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. * 7\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments. * 8\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria. * 9\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection. * 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. * 11\. Has previously received organ transplantation. * 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. * 13\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose. * 14\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures. * 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. * 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. * 17\. Is pregnant or breastfeeding. * 18\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | Through the end of the safety follow-up period, an average of 60 weeks | Adverse events will be assessed according to the protocol-defined safety assessment criteria. |
| Number of participants with dose-limiting toxicities | Through the end of the safety follow-up period, an average of 60 weeks | Dose-limiting toxicities will be assessed according to protocol-defined criteria. |
Contacts
CONTACTLina Chen
Outcome results
None listed