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

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

Study Overview

• Status: Not yet recruiting
• Conditions: HBV Infection
• Intervention / Treatment: Other: Adjuvant; Drug: TVAX-028

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lina Chen; Phone Number: 086+19921306230; Email: chenlina@theravac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adjuvant Group; Participants receive adjuvant alone	Other: Adjuvant; Adjuvant will be administered alone in the adjuvant group
Experimental: TVAX-028 low-dose group; Participants receive low-dose TVAX-028 with adjuvant	Drug: TVAX-028; TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.
Experimental: TVAX-028 medium-dose group; Participants receive medium-dose TVAX-028 with adjuvant	Drug: TVAX-028; TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.
Experimental: TVAX-028 high-dose group; Participants receive high-dose TVAX-028 with adjuvant	Drug: TVAX-028; TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Chemical Actions and Uses; Specialty Uses of Chemicals; Pharmaceutic Aids; Adjuvants, Pharmaceutic
• Other Study ID Numbers: YDSWX(TVAX-028)-001(I)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No