New shot aims to tame chronic hepatitis b

NCT ID NCT07275918

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study tests a new medicine called SA1211 for chronic hepatitis B, a long-term liver infection. Researchers will check safety and how the body processes the drug in 80 healthy volunteers and people with hepatitis B. The goal is to see if it can help control the virus, not cure it.

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 80 people

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

Started

Nov 2025

Expected to finish

Mar 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. Able to correctly understand and sign the informed consent form in writing. 2. Male or female participants. * For healthy participants: aged 18-55 years old (inclusive of the cut-off values). * For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values). 3. Body Mass Index (BMI) meets the following requirements. * For healthy participants: within the range of 18-28 kg/m² (inclusive of the cut-off values). * For participants with chronic hepatitis B (CHB): within the range of 18-32 kg/m² (inclusive of the cut-off values). 4. During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant: \- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray. 5. For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and/or positive HBV deoxyribonucleic acid (HBV DNA). 6. For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period. 7. For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners. Exclusion Criteria: 1. Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured. 2. Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors. 3. Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression. 4. Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator. 5. Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period. 6. Participants with severe infection or trauma within 4 weeks before screening. 7. Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components. 8. Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening. 9. Participants deemed unsuitable for the trial by the investigator due to other factors.

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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 First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130031, China

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