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Can a new injection tame chronic hepatitis b?

NCT ID NCT07741461

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This early-stage trial is evaluating an investigational drug called ACT201, given as an injection, to see if it is safe and tolerable. The study first tests single and multiple doses in healthy volunteers, then moves to people with chronic hepatitis B whose virus is already suppressed by standard therapy. The goal is to gather initial information on safety, how the drug moves through the body, and any early signs that it might help control the infection.

What this could mean

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

Active substance
ACT201 injection
What this could lead to
If successful, this could lead to a new treatment option for chronic hepatitis B, potentially helping to control the infection and reduce liver damage.
What could go wrong
This is an early-stage trial, so the drug may not be safe or effective. Side effects are possible, and results in a small group may not apply to a larger population.

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 72 people

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

Started

Aug 2026

Expected to finish

Apr 2027

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: Part 1: * Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent; * Aged between 18 and 55 years old (inclusive) at the time of informed consent, male or female; * Body mass index meets specified criteria; * Physical examination, vital signs, laboratory tests, electrocardiogram and imaging examinations at screening are normal or abnormalities are considered clinically insignificant; * Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation. Part 2: * Participants fully understand the purpose, nature and methods of the trial as well as potential adverse events, voluntarily participate in this trial and provide written informed consent; * Aged between 18 and 65 years old (inclusive) at the time of informed consent, male or female; * Body mass index meets specified criteria; * HBsAg-positive or HBV DNA-positive for at least 6 months, or previous liver biopsy confirming chronic HBV infection; * Receiving stable nucleos(t)ide analogue (NA) therapy at screening, with no planned changes to NA regimen during the trial; * Serum ALT ≤ 2 × ULN at screening; HBeAg, HBV DNA and HBsAg levels meet protocol-specified criteria; * Participants (including their partners) are willing to use effective contraceptive measures from screening through 6 months after the last administration of investigational product, with no plans for pregnancy, sperm donation or oocyte donation. Exclusion Criteria: Part 1: * Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator). * History of clinically significant diseases involving cardiovascular, hematologic and lymphatic, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy). * Vital signs or laboratory examinations at screening meet the exclusion cut-off values specified in the protocol. * Use of any prescription drugs, over-the-counter medications, vitamin products or herbal medicines within 2 weeks prior to the first dose (topical medications with local effects are excluded). * Positive HBsAg, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody at screening. * QTcF interval (QT corrected by Fridericia's formula) \> 450 ms at screening. * Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening. * History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening. * History of alcohol abuse within 6 months before screening (14 alcohol units per week: 1 unit = 285 mL beer with \~3.5% alcohol, or 25 mL spirits with \~40% alcohol, or 100 mL wine with \~10% alcohol), or positive breath alcohol test at screening. * Vaccination administered within 1 month before screening, or planned vaccination during the trial period. * Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period. * Female participants who are breastfeeding or have a positive serum pregnancy test at screening. * Participation in any clinical trial with an investigational medicinal product/investigational device within 3 months before screening or within 5 half-lives (whichever is longer). * Any other condition deemed unsuitable for trial participation by the Investigator. Part 2: * Major trauma or major surgery within 3 months before screening; or planned surgery during the trial period that may impair trial compliance or safety assessment as assessed by the Investigator. * Uncontrolled and clinically significant abnormalities other than chronic HBV infection, such as acute cerebrovascular disease, severe or unstable cardiac disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled dyslipidemia, etc. * History of other clinically significant liver diseases. * History of liver cirrhosis or progressive liver fibrosis; or liver stiffness measurement (LSM) ≥ 8.5 kPa at screening. * Alpha-fetoprotein \> 50 ng/mL, or imaging suggestive of possible malignant hepatic lesions. * Past or current manifestations of hepatic decompensation. * History of extrahepatic diseases potentially related to HBV immune status. * History of vasculitis; or signs/symptoms suggestive of underlying vasculitis; or past/current other diseases potentially associated with vasculitic disorders. * Active infection requiring systemic antiviral or antibacterial treatment at screening, excluding HBV infection. * History of malignant tumors within 5 years before screening, except for specific curable cancers resected surgically. * Prior solid organ or bone marrow transplantation. * Use of systemic immunosuppressants within 3 months before the first dose of investigational product \[short-term (≤7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune diseases excluded\]; use of immunomodulators or cytotoxic agents within 6 months before the first dose of investigational product. * Receipt of any oligonucleotide or small interfering RNA (siRNA) therapy within 12 months before the first dose of investigational product. * Coexisting indication for anticoagulant therapy or anticipated requirement for anticoagulation during the trial. * Any of the following laboratory results at screening, or other clinically significant abnormalities rendering the participant unsuitable for trial participation: Platelet count \< 125 × 10\^9/L Absolute neutrophil count \< 1.5 × 10\^9/L Hemoglobin \< 100 g/L Total bilirubin \> 1.25 × ULN Serum albumin \< 35 g/L Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2 (calculated using the CKD-EPI formula) Prothrombin time international normalized ratio (INR) \> 1.25 Positive hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody * QTcF interval (QT corrected by Fridericia's formula) \> 450 ms at screening, or other clinically significant electrocardiogram abnormalities identified at screening. * Known or suspected hypersensitivity to ACT201 or its excipients; or participants with allergic diathesis (multiple drug and food allergies judged clinically significant by the Investigator). * Daily cigarette consumption exceeding 5 cigarettes within 3 months before screening. * History of drug abuse or illicit drug use within 1 year before screening, or positive urine drug screen at screening. * History of alcohol abuse within 6 months before screening, or positive breath alcohol test at screening. * Vaccination administered within 1 month before screening, or planned vaccination during the trial period. * Blood loss or blood donation ≥ 400 mL within 3 months before screening (menstrual bleeding in female participants excluded), or planned blood donation during the trial period. * Female participants who are breastfeeding or have a positive serum pregnancy test at screening. * Participation in any clinical trial with an investigational medicinal product/investigational device within 3 months before screening or within 5 half-lives (whichever is longer). * Any other condition deemed unsuitable for trial participation by the 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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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