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New shot aims to silence hepatitis b virus for good

NCT ID NCT07630727

Disease control Sponsor: Ausper Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 22, 2026 · Updated 5 times

Summary

This Phase 2 trial tests an injection called AHB-171 in 138 people with chronic hepatitis B. The goal is to see if it can lower hepatitis B surface antigen and viral DNA to very low levels, potentially leading to a functional cure. Participants include those who have never been treated and those already on antiviral therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AHB-171 injection
What this could lead to
If successful, this could point toward a functional cure for chronic hepatitis B, where the virus is suppressed to very low or undetectable levels without lifelong medication.
What could go wrong
This is an early Phase 2 trial with only 138 participants, so results may not apply to everyone. The treatment may not achieve lasting viral suppression, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to fully understand and sign the informed consent form (ICF). * Male or female participants, aged 18-65 years (inclusive). * Body mass index (BMI) meeting the predefined eligibility range. * Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening. * At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements. * Adopt effective contraceptive measures as required Exclusion Criteria: * History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation. * Prior history of solid organ or hematopoietic stem cell transplantation. * History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk. * History or presence of hepatic decompensation at screening. * History of primary liver cancer, or diagnosis/suspected liver cancer at screening. * Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening * History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation. * Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection). * History of drug abuse, or alcoholism. * Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period. * Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening. * Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening. * Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period. * Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions. * Clinically significant abnormal electrocardiogram (ECG) at screening. * Tested positive for HIV，HCV or active syphilis infection. * Uncontrolled hypertension at screening. * Clinically significant abnormal laboratory test as specified in protocol at screening. * Currently participating in another clinical trials, or within the washout period. * Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B, chronic (CHB)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AusperBio Investigational Site

    RECRUITING

    Beijing, Beijing Municipality, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Chongqing, Chongqing Municipality, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Xiamen, Fujian, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Nanning, Guangxi, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Zhengzhou, Henan, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Changzhou, Jiangsu, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Jilin City, Jilin, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuang, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Hangzhou, Zhejiang, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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