A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 1/2 Study to Evaluate AHB-137 Injection Followed by TVAX-008 Injection in Participants With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogs

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07876856

Enrollment

105

Registered

2026-10-15

Start date

2026-10-31

Completion date

2029-06-20

Last updated

2026-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Brief summary

This is a study of sequential therapy with AHB-137 injection followed by TVAX-008 injection in participants living with Chronic Hepatitis B (CHB).

Interventions

DRUGAHB-137

AHB-137 will be administered per 1 week.

DRUGPlacebo

Placebo will be used per 4 weeks.

DRUGTVAX-008

TVAV-008 will be administered per 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Voluntarily participate in the study and sign the informed consent form, and comply with the requirements of the study protocol; * 18-65 years of age (including boundary values) for men or women; * Body mass index met the requirements; * HBeAg negative at screening; * Meet the relevant requirements for prior medications; * HBsAg and HBV DNA and liver function indicators meet the requirements; * Use contraception as required;

Exclusion criteria

* Uncontrolled and stable clinically significant abnormalities or other serious diseases other than a history of chronic HBV infection; * Has received treatment with the relevant medication; * Participants with clinically significant relevant liver diseases, manifestations of liver function decompensation, history of extrahepatic diseases related to HBV immune status, liver fibrosis or cirrhosis, and confirmed or suspected liver cancer; * Any serious infection other than chronic hepatitis B infection requires intravenous anti-infective therapy; * HCV RNA positive, HIV antibody positive, syphilis positive within 12 months; * Abnormal laboratory results; * Diseases associated with vascular inflammatory conditions; * QT interval corrected heart rate (Fridericia method) abnormal; * History of malignancy or ongoing assessment of possible malignancy; * History of allergies, or allergic constitution; * Recent major trauma or major surgery, or planned surgery; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Prior/current use of prohibited medications; * Thyroid function abnormal; * There are serious cardiovascular and cerebrovascular diseases; * Inappropriate for participation in this trial as judged by the investigator.

Design outcomes

Primary

Measure	Time frame	Description
Safety indicators of Phase 1	Up to 72 weeks.	The incidence and severity of adverse events and levels and changes in laboratory tests, electrocardiograms, physical examinations and vital signs.
HBV DNA < LLOQ and HBsAg < LOD, 0.05 IU/mL with or without HBsAb 24 weeks after discontinuation of all CHBs of Phase 2	Up to 72 weeks	—

Contacts

CONTACTBella Lu

clinicaltrial@ausperbio.com057186959519

PRINCIPAL_INVESTIGATORGuiqiang Wang

Peking University First Hospital

PRINCIPAL_INVESTIGATORYan Wang