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

ConditionHBV Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrand Theravac Life Sciences (Nanjing) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • TVAX-028

    Drug

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

  • Adjuvant

    Other intervention

    Adjuvant will be administered alone in the adjuvant group

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Adjuvant GroupOther 1 intervention
Group B: TVAX-028 low-dose groupExperimental treatment 1 intervention
Group C: TVAX-028 medium-dose groupExperimental treatment 1 intervention
Group D: TVAX-028 high-dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events

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

Time frame
Through the end of the safety follow-up period, an average of 60 weeks
2

Number of participants with dose-limiting toxicities

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grand Theravac Life Sciences (Nanjing) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: