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Can a new injection tame chronic hepatitis b?

NCT ID NCT07771140

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This early-stage trial is testing an investigational drug called HECN30227, given as an injection, in healthy volunteers and in people with chronic hepatitis B. The study aims to assess the drug's safety, how the body processes it, and its potential to reduce the virus. Participants receive either the drug or a placebo, with some receiving a single dose and others multiple doses.

What this could mean

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

Active substance
HECN30227 injection
What this could lead to
If successful, this could lead to a new treatment option for chronic hepatitis B, potentially reducing or clearing the virus.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is too soon to know if the drug will be effective. Possible side effects are still being evaluated.

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 78 people

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

Started

Dec 2025

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: 1. Subjects must understand and comply with the study procedures, voluntarily participate, and sign the informed consent form. 2. Male subjects must weigh at least 50 kg; female subjects must weigh at least 45 kg. 3. Vital signs, physical examination, laboratory tests, electrocardiography (ECG), chest X-ray, and abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys) are normal, or abnormalities are judged by the investigator to be clinically insignificant. 4. Female subjects of childbearing potential or male subjects must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of study drug. 5. Subjects must have received stable treatment with nucleos(t)ide analogues (NAs) (e.g., entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide) for at least 6 months prior to screening. 6. HBV DNA \< 90 IU/mL at screening. 7. HBsAg \> 100 IU/mL at screening. 8. Serum ALT and AST ≤ 2 × ULN, and total serum bilirubin ≤ 2 × ULN at screening and baseline. Exclusion Criteria: 1. Subjects who have undergone major surgery within 3 months prior to screening, or plan to undergo surgery during the study period. 2. Subjects with a history of allergy to the study drug or any of its components, or with allergic diathesis (allergic to two or more types of drugs or foods). 3. Subjects with a history of alcohol abuse within 1 year prior to screening , or those with a positive blood alcohol test result prior to dosing. 4. Subjects with a history of drug abuse or use of illicit drugs within 1 year prior to screening, or those with a positive urine drug screening result prior to dosing. 5. Subjects who donated blood ≥200 mL, or donated any blood component, or suffered a total blood loss ≥200 mL for any reason within 3 months prior to screening; or those with a history of blood transfusion or blood product administration. 6. Subjects who participated in another clinical trial within 3 months prior to screening. 7. Subjects who develop an acute illness (e.g., acute respiratory disease) or receive concomitant medication from the time of signing the informed consent form to prior to the first dose. 8. Subjects who are breastfeeding or have a positive serum pregnancy test result. 9. Subjects with significant hepatic fibrosis or liver cirrhosis. 10. Subjects with a history of hepatic decompensation manifestations or disease at screening or in the past, including but not limited to ruptured esophageal and gastric variceal bleeding, ascites, hepatic encephalopathy, etc. 11. Subjects diagnosed with any malignant tumor within 5 years prior to screening , or those assessed to have potential malignant tumors at present. 12. Subjects with international normalized ratio (INR) \>1.5, or platelet count \<90×10⁹/L, or serum albumin \<35 g/L at screening. 13. Subjects with alpha-fetoprotein (AFP) \>50 ng/mL at screening. 14. Subjects with endogenous creatinine clearance (CLcr) \<60 mL/min/1.73 m² at screening. 15. Subjects receiving, or who have received any interferon-containing regimen or immunosuppressive therapy within 1 year prior to screening. 16. Subjects whom the investigator considers unsuitable for participation in this trial for any other reasons.

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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

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

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