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

NCT07673068 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-06-29

No results posted yet for this study

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

Interventions

DRUG

TVAX-028

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

OTHER

Adjuvant

Adjuvant will be administered alone in the adjuvant group

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07673068 on ClinicalTrials.gov