New shot aims to slash hepatitis b virus levels
NCT ID NCT05961098
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic hepatitis B are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Safety and efficacy of sequential treatment with a PD-1 antibody and pegylated interferon-α in Nucleos(t)Ide Analogue-Suppressed patients with chronic hepatitis b
- Can a new pill push hepatitis b virus to undetectable levels?
- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?
- Could a simple scan and blood test outsmart liver cancer?