A Study of RBD1016 in CHB Participants

NCT05961098 | Completed Phase 2 DMC

• 1 other identifier: RBHB1203
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  24 weeks

Secondary Outcomes (8)

• efficacy: the proportion of HBsAg decline≥1 log10 IU/mL

  24 weeks

• PK parameter Cmax

  12 weeks

• PK parameter Tmax

  12 weeks

• PK parameter AUC0-t

  12 weeks

• PK parameter t1/2

  12 weeks

Study Arms (3)

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.

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.

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.

Drug: RBD1016

Interventions

RBD1016 DRUG

RBD1016 with NAs background treatment will be explored.

RBD1016/placebo 100 mg Q4W group; RBD1016/placebo 200 mg Q12W group; RBD1016/placebo 200 mg Q4W group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Ribo Life Science Co. Ltd.: lead

Study Sites (4)

Prince of Wales Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Karolinska University Hospital

Stockholm, Stockholm County, 141 86, Sweden

Location

Clinical Trial Consultants AB

Uppsala, Uppsala County, 752 37, Sweden

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: October 11, 2023
• Primary Completion: April 29, 2025
• Study Completion: October 15, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); CN (2)