A Study of RBD1016 in CHB Participants

December 8, 2025 updated by: Suzhou Ribo Life Science Co. Ltd.

A Phase II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of RBD1016 Injection in Participants With Chronic Hepatitis B

This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of screening period, treatment period, and FU period. It is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 16 eligible participants, with 12 participants receiving RBD1016 injection and 4 participants receiving placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • Queen Mary Hospital
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 141 86
        • Karolinska University Hospital
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 752 37
        • Clinical Trial Consultants AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RBD1016/placebo 100 mg Q4W group
Participants in the 100 mg Q4W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, D29, D57, and D85.
Drug: RBD1016
RBD1016 with NAs background treatment will be explored.
Experimental: RBD1016/placebo 200 mg Q4W group
Participants in the 200 mg Q4W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, D29, D57, and D85.
Drug: RBD1016
RBD1016 with NAs background treatment will be explored.
Experimental: RBD1016/placebo 200 mg Q12W group
Participants in the 200 mg Q12W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, and D85.
Drug: RBD1016
RBD1016 with NAs background treatment will be explored.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
safety: number and percentage of AEs
Time Frame: 24 weeks
Number and percentage of participants with adverse events (AEs). All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).
24 weeks
efficacy: the maximum decline of HBsAg level
Time Frame: 24 weeks
The maximum decline (log value) of HBsAg level. Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
efficacy: the proportion of HBsAg decline≥1 log10 IU/mL
Time Frame: 24 weeks
The proportion of participants with HBsAg decline ≥1 log10 IU/mL. Electro chmiluminescence method will be used to detect HBsAg.
24 weeks
PK parameter Cmax
Time Frame: 12 weeks
Maximum concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks
PK parameter Tmax
Time Frame: 12 weeks
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
12 weeks
PK parameter AUC0-t
Time Frame: 12 weeks
Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks
PK parameter t1/2
Time Frame: 12 weeks
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks
PK parameter Vd/F
Time Frame: 12 weeks
Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks
PK parameter CL/F
Time Frame: 12 weeks
Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks
PK parameter Css
Time Frame: 12 weeks
Steady state concentration (Css) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Ribo Life Science Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jidong Jia, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHB1203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings