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Not yet recruitingNCT07876856Updated Oct 19, 2026

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

A Phase 1/2 interventional study of AHB-137 and Placebo in Chronic Hepatitis B, sponsored by Ausper Biopharma Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Ausper Biopharma Co., Ltd. · Phase 1/2, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Chronic Hepatitis B

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Keywords

  • Hepatitis B, Chronic
03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's planned enrollment of 105 is close to the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Ausper Biopharma Co., Ltd. is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Experiment group

    Drug: AHB-137 · Drug: TVAX-008

  • Placebo comparator
    Placebo group

    Drug: AHB-137 · Drug: Placebo

Interventions

  • AHB-137 will be administered per 1 week.

  • DrugPlacebo

    Placebo will be used per 4 weeks.

  • TVAV-008 will be administered per 4 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 72 weeks.

  2. HBV DNA < LLOQ and HBsAg < LOD, 0.05 IU/mL with or without HBsAb 24 weeks after discontinuation of all CHBs of Phase 2

    Time frame: Up to 72 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 2 updates
  1. Oct 19, 2026
    Minor edits only
    + 1 other change: responsible party
  2. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876856
Collaborators
Grand Theravac Life Sciences (Hangzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Sep 22, 2028 (estimated)
Completion
Jun 20, 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Bella Lu
Contact
clinicaltrial@ausperbio.com
057186959519
Guiqiang Wang
principal investigator · Peking University First Hospital
Yan Wang
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TVAX-008

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