Chronic Hepatitis bPhase 2NCT05961098
A Study of RBD1016 in CHB Participants
A Phase 2 study testing RBD1016 in people with Chronic Hepatitis b, run by Suzhou Ribo Life Science Co. Ltd. at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- RBD1016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Oct 2023to 15 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give written informed consent for study participation;
- Male or female participants aged 18-65 years;
- Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
- Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
- HBeAg positive or negative at screening;
- On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs;
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- HBV DNA level <100 IU/mL at screening;
- HBsAg level ≥50 IU/mL at screening;
- Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN);
- 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;
Who cannot join
- Diagnosed with other liver diseases other than hepatitis B;
- History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
- History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
- Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
- 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;
- Those who the investigator believes are not suitable to participate in the study due to other factors.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Sweden2 sites
Karolinska University Hospital
Stockholm, Stockholm County, 141 86
Clinical Trial Consultants AB
Uppsala, Uppsala County, 752 37
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis b
- Being tested
- RBD1016
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1016Drug
RBD1016 with NAs background treatment will be explored.
| Study group | Role | What they receive |
|---|---|---|
| RBD1016/placebo 100 mg Q4W group | Experimental | 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. Receives: Drug: RBD1016 |
| RBD1016/placebo 200 mg Q4W group | Experimental | 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. Receives: Drug: RBD1016 |
| RBD1016/placebo 200 mg Q12W group | Experimental | Participants in the 200 mg Q12W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, and D85. Receives: Drug: RBD1016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety: number and percentage of AEs
Number and percentage of participants with adverse events (AEs). All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).
Measured: 24 weeks
efficacy: the maximum decline of HBsAg level
The maximum decline (log value) of HBsAg level. Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
Measured: 24 weeks
Secondary outcomes (8)
efficacy: the proportion of HBsAg decline≥1 log10 IU/mL
The proportion of participants with HBsAg decline ≥1 log10 IU/mL. Electro chmiluminescence method will be used to detect HBsAg.
Measured: 24 weeks
PK parameter Cmax
Maximum concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: 12 weeks
PK parameter Tmax
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
Measured: 12 weeks
PK parameter AUC0-t
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).
Measured: 12 weeks
PK parameter t1/2
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: 12 weeks
PK parameter Vd/F
Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: 12 weeks
PK parameter CL/F
Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: 12 weeks
PK parameter Css
Steady state concentration (Css) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start11 Oct 2023
- Primary completion29 Apr 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961098
- Sponsor's protocol ID
- RBHB1203
- Status last verified
- Dec 2025
- First submitted
- 6 Jul 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of RBD1016 Injection in Participants With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT05961098
- Acronym / sponsor ID
- RBHB1203
- Conditions
- Chronic Hepatitis b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RBD1016/placebo 100 mg Q4W group | Experimental | Drug: RBD1016Participants 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. |
| RBD1016/placebo 200 mg Q4W group | Experimental | Drug: RBD1016Participants 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. |
| RBD1016/placebo 200 mg Q12W group | Experimental | Drug: RBD1016Participants in the 200 mg Q12W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, and D85. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing and able to give written informed consent for study participation;
- Male or female participants aged 18-65 years;
- Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
- Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
- HBeAg positive or negative at screening;
Key exclusion criteria (6 listed)
- Diagnosed with other liver diseases other than hepatitis B;
- History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
- History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
- Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD1016RBD1016 with NAs background treatment will be explored. | Drug | RBD1016/placebo 100 mg Q4W group, RBD1016/placebo 200 mg Q12W group, RBD1016/placebo 200 mg Q4W group |
Primary outcome
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).
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).
8 secondary outcomes
efficacy: the proportion of HBsAg decline≥1 log10 IU/mL
Time frame: 24 weeks
PK parameter Cmax
Time frame: 12 weeks
PK parameter Tmax
Time frame: 12 weeks
PK parameter AUC0-t
Time frame: 12 weeks
PK parameter t1/2
Time frame: 12 weeks
PK parameter Vd/F
Time frame: 12 weeks
PK parameter CL/F
Time frame: 12 weeks
PK parameter Css
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD1016 in people with Chronic Hepatitis b, run by Suzhou Ribo Life Science Co. Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety: number and percentage of AEs (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.