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New injection aims to suppress hepatitis b virus

NCT ID NCT07635186

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This phase 2 trial tests an injection called AHB-137 in adults with chronic hepatitis B who have not yet received treatment. The study compares AHB-137 to a placebo to see if it can lower the amount of hepatitis B virus in the blood and reduce a key marker of infection (HBsAg). Participants will receive multiple doses and be followed for 24 weeks after treatment ends.

What this could mean

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

Active substance
AHB-137
What this could lead to
If successful, AHB-137 could offer a new treatment option that helps control chronic hepatitis B and reduces the risk of liver damage.
What could go wrong
This is an early-phase trial with a small number of participants. The drug may not work as expected or could cause side effects. Results may not apply to all patients.

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 320 people

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

Started

Jun 2026

Expected to finish

Jun 2028

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: * Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol. * Aged 18-65 years (including boundary values). * Body mass index between the range of 18-32 kg/m2 (inclusive boundary values). * HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue. * HBsAg and HBV DNA values met protocol requirements at screening. * ALT \< 3xULN at screening. * Use highly effective contraception as required. Exclusion Criteria: * Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection. * Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status. * Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization. * Hepatitis C virus (HCV) infection or \< 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive). * Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \> 9.0 kPa at screening. * Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy. * Laboratory test results do not meet the criteria. * Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis. * Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening. * Allergic to AHB-137 ingredients, or history of drug allergy or other allergies. * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial. * Participants are participating in another clinical trial or failing to wash out as required. * Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial. * Participants that require regular long-term anticoagulants. * Abnormal thyroid function. * Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B. * Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.

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Conditions

The condition(s) this trial relates to.

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.

Chronic hepatitis B

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

    34 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: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Chongqing, Chongqing Municipality, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Xiamen, Fujian, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Jiangmen, Guangdong, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Meizhou, Guangdong, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Qingyuan, Guangdong, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Shenzhen, Guangdong, China

  • AusperBio Investigational Site

    RECRUITING

    Shenzhen, Guangdong, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Liuzhou, Guangxi, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Wuhan, Hubei, China

  • AusperBio Investigational Site

    RECRUITING

    Wuhan, Hubei, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Yichang, Hubei, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Changsha, Hunan, China

  • AusperBio Investigational Site

    RECRUITING

    Changsha, Hunan, China

  • AusperBio Investigational Site

    RECRUITING

    Changsha, Hunan, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Nanjing, Jiangsu, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Nanchang, Jiangxi, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Changchun, Jilin, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Shenyang, Liaoning, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • AusperBio Investigational Site

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • AusperBio Investigational Site

    RECRUITING

    Shanghai, Shanghai Municipality, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Xi’an, Shanxi, China

  • AusperBio Investigational Site

    RECRUITING

    Xi’an, Shanxi, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuan, China

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuan, China

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuan, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Kunming, Yunan, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Hangzhou, Zhejiang, China

    Contact Email: •••••@•••••

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

    Contact Email: •••••@•••••

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.