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New shot aims to tame chronic hepatitis b

NCT ID NCT07511218

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Updated 2 times

Summary

This early-stage study tests an injection called AHB-171 in healthy volunteers and people with chronic hepatitis B. The main goals are to check safety, how the body processes the drug, and whether it shows any signs of controlling the virus. About 110 participants will be enrolled to gather this initial information.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

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

Started

Apr 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

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy Participants: * Male or female participants, aged 18-55 years old (inclusive); * Body mass index between 18.0 and 28.0 kg/m\^2 (inclusive); * Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance; * Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug. * Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening. * CHB Participants: * Male or female participants, aged 18-65 years old (inclusive); * Body mass index between 18.0 and 32.0 kg/m\^2 (inclusive); * Participants who take effective contraceptive measures as required; * HBsAg \> 100 IU/mL and ≤ 3000 IU/mL, and HBV DNA \< 100 IU/mL at screening. * Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening. Exclusion Criteria: * Healthy Participants: * Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product. * Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months. * Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening. * Allergy to any investigational drug component. * Heavy Smoking (\> 5 cigarettes/day); history of drug/alcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing. * Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study. * Abdominal skin issues that may affect drug injection/observation. * Positive for HBV, HCV, HIV, or syphilis. * Clinically significant ECG abnormality or TdP risk factors. * Any condition judged unsuitable by investigator. * CHB Participants: * Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product. * Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices. * History or suspicion of hepatocellular carcinoma (HCC); AFP \> 50 ng/mL. * Diagnosed or Suspected cirrhosis within 12 months. * History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV). * Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months. * Major injury/surgery within 6 months, planned surgery during study, or acute infection within 14 days. * Allergy to any investigational drug component. * Blood donation/loss ≥400 mL or transfusion within 12 weeks, or plan to donate during study. * Abdominal skin issues that may affect drug injection/observation. * Key laboratory result not suitable for clinical trial. * HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E. * Clinically significant ECG abnormality or TdP risk factors. * Any condition judged unsuitable by investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    2 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

    Ch’ang-ch’un, Jilin, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Hangzhou, Zhejiang, 310052, China

    Contact Email: •••••@•••••

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