HBV InfectionPhase 1NCT07673068
Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B
A Phase 1 study testing TVAX-028 and Adjuvant in people with HBV Infection, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBV Infection
- What is being tested?
- TVAX-028 and Adjuvant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- HBV Infection
- Being tested
- TVAX-028, Adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVAX-028Drug
TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups.
AdjuvantOther
Adjuvant will be administered alone in the adjuvant group
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Group | Other | Participants receive adjuvant alone Receives: Other: Adjuvant |
| TVAX-028 low-dose group | Experimental | Participants receive low-dose TVAX-028 with adjuvant Receives: Drug: TVAX-028 |
| TVAX-028 medium-dose group | Experimental | Participants receive medium-dose TVAX-028 with adjuvant Receives: Drug: TVAX-028 |
| TVAX-028 high-dose group | Experimental | Participants receive high-dose TVAX-028 with adjuvant Receives: Drug: TVAX-028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Adverse events will be assessed according to the protocol-defined safety assessment criteria.
Measured: 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.
Measured: Through the end of the safety follow-up period, an average of 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673068
- Sponsor's protocol ID
- YDSWX(TVAX-028)-001(I)
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07673068
- Acronym / sponsor ID
- YDSWX(TVAX-028)-001(I)
- Conditions
- HBV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Grand Theravac Life Sciences (Nanjing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Group | Other | Other: AdjuvantParticipants receive adjuvant alone |
| TVAX-028 low-dose group | Experimental | Drug: TVAX-028Participants receive low-dose TVAX-028 with adjuvant |
| TVAX-028 medium-dose group | Experimental | Drug: TVAX-028Participants receive medium-dose TVAX-028 with adjuvant |
| TVAX-028 high-dose group | Experimental | Drug: TVAX-028Participants receive high-dose TVAX-028 with adjuvant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVAX-028TVAX-028 will be administered with adjuvant at low, medium, or high dose levels in the investigational dose groups. | Drug | TVAX-028 high-dose group, TVAX-028 low-dose group, TVAX-028 medium-dose group |
| AdjuvantAdjuvant will be administered alone in the adjuvant group | Other | Adjuvant Group |
Primary outcome
Number of participants with adverse events
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TVAX-028 and Adjuvant in people with HBV Infection, run by Grand Theravac Life Sciences (Nanjing) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Chen (086+19921306230, chenlina@theravac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Through the end of the safety follow-up period, an average of 60 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.