NCT07876856

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
32mo left

Started Oct 2026

Typical duration for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

October 31, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2028

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2029

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

1.9 years

First QC Date

October 9, 2026

Last Update Submit

October 9, 2026

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (2)

  • Safety indicators of Phase 1

    The incidence and severity of adverse events and levels and changes in laboratory tests, electrocardiograms, physical examinations and vital signs.

    Up to 72 weeks.

  • 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

Study Arms (2)

Experiment group

EXPERIMENTAL
Drug: AHB-137Drug: TVAX-008

Placebo group

PLACEBO COMPARATOR
Drug: AHB-137Drug: Placebo

Interventions

AHB-137DRUG

AHB-137 will be administered per 1 week.

Experiment groupPlacebo group
PlaceboDRUG

Placebo will be used per 4 weeks.

Placebo group
TVAX-008DRUG

TVAV-008 will be administered per 4 weeks.

Experiment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily participate in the study and sign the informed consent form, and comply with the requirements of the study protocol;
  • 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;

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guiqiang Wang

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Yan Wang

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bella Lu

CONTACT

057186959519clinicaltrial@ausperbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2026

First Posted

October 15, 2026

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

September 22, 2028

Study Completion (Estimated)

June 20, 2029

Last Updated

October 15, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share