New shot aims to slash hepatitis b virus levels

NCT ID NCT05961098

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental injection called RBD1016 in 48 adults with chronic hepatitis B who were already taking standard antiviral pills. The goal was to see if the injection could safely lower hepatitis B surface antigen (HBsAg), a marker of the virus. Participants received either RBD1016 or a placebo, and researchers tracked side effects and changes in HBsAg levels over time.

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

48 people

The number who actually took part.

Started

Oct 2023

Finished

Oct 2025

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: 1. Willing and able to give written informed consent for study participation; 2. Male or female participants aged 18-65 years; 3. Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2); 4. Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening; 5. HBeAg positive or negative at screening; 6. On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs; 7. HBV DNA level \<100 IU/mL at screening; 8. HBsAg level ≥50 IU/mL at screening; 9. Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN); 10. Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2; Exclusion Criteria: 1. Diagnosed with other liver diseases other than hepatitis B; 2. History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening; 3. History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions; 4. Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E; 5. Laboratory results at screening as follows: serum alpha-fetoprotein (AFP) \>50 μg/L; serum albumin concentration \<3.0 g/dL; international normalized ratio (INR) \>1.5; platelet count \<90×10\^9/L; serum direct bilirubin (DB) \>2×ULN; serum creatinine concentration \>1.5×ULN or creatinine clearance \<60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this study; 6. Those who the investigator believes are not suitable to participate in the study 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.

Contacts and locations

Locations

  • Clinical Trial Consultants AB

    Uppsala, Uppsala County, 752 37, Sweden

  • Karolinska University Hospital

    Stockholm, Stockholm County, 141 86, Sweden

  • Prince of Wales Hospital

    Hong Kong, China

  • Queen Mary Hospital

    Hong Kong, China

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