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NOT YET RECRUITING
NCT07673068
PHASE1

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

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

View on ClinicalTrials.gov

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

Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-05-31

Completion Date

2027-05-31

Last Updated

2026-06-29

Healthy Volunteers

No

Conditions

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