Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B

NCT07673068 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: YDSWX(TVAX-028)-001(I)
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Conditions

HBV Infection

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events

  Adverse events will be assessed according to the protocol-defined safety assessment criteria.

  Through the end of the safety follow-up period, an average of 60 weeks

• Number of participants with dose-limiting toxicities

  Dose-limiting toxicities will be assessed according to protocol-defined criteria.

  Through the end of the safety follow-up period, an average of 60 weeks

Study Arms (4)

Adjuvant Group

OTHER

Participants receive adjuvant alone

Other: Adjuvant

TVAX-028 low-dose group

EXPERIMENTAL

Participants receive low-dose TVAX-028 with adjuvant

Drug: TVAX-028

TVAX-028 medium-dose group

EXPERIMENTAL

Participants receive medium-dose TVAX-028 with adjuvant

Drug: TVAX-028

TVAX-028 high-dose group

EXPERIMENTAL

Participants receive high-dose TVAX-028 with adjuvant

Drug: TVAX-028

Interventions

TVAX-028 DRUG

TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.

TVAX-028 high-dose group; TVAX-028 low-dose group; TVAX-028 medium-dose group

Adjuvant OTHER

Adjuvant will be administered alone in the adjuvant group

Adjuvant Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.
• \. Male or female, aged 18 to 65 years.
• \. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.
• \. 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.
• \. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.
• \. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028.
• \. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.
• \. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.

You may not qualify if:

• \. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results
• \. 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.
• \. 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.
• \. 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.
• \. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028.
• \. 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.
• \. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.
• \. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.
• \. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.
• \. 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.
• \. Has previously received organ transplantation.
• \. 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.
• \. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.
• \. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.
• \. 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.

Sponsors & Collaborators

• Grand Theravac Life Sciences (Nanjing) Co., Ltd.: lead

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

Lina Chen

CONTACT

086+19921306230; chenlina@theravac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 29, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share