A Study of RBD1016 in CHB Participants

Phase 2

Active, not recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: RBD1016

• Registration Number: NCT05961098
• Lead Sponsor: Suzhou Ribo Life Science Co. Ltd.

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.

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 Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-07-27
• Study Start: 2023-10-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-21
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RBD1016/placebo 100 mg Q4W group	RBD1016	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.
RBD1016/placebo 200 mg Q4W group	RBD1016	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.
RBD1016/placebo 200 mg Q12W group	RBD1016	Participants in the 200 mg Q12W dose group will receive corresponding doses of RBD1016 injection or placebo by subcutaneous injection on D1, and D85.

Primary Outcome Measures

Name	Time	Method
safety: number and percentage of AEs	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	24 weeks	The maximum decline (log value) of HBsAg level. Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).

Secondary Outcome Measures

Name	Time	Method
efficacy: the proportion of HBsAg decline≥1 log10 IU/mL	24 weeks	The proportion of participants with HBsAg decline ≥1 log10 IU/mL. Electro chmiluminescence method will be used to detect HBsAg.
PK parameter Cmax	12 weeks	Maximum concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
PK parameter Tmax	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.
PK parameter AUC0-t	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).
PK parameter t1/2	12 weeks	Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
PK parameter Vd/F	12 weeks	Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
PK parameter CL/F	12 weeks	Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
PK parameter Css	12 weeks	Steady state concentration (Css) will be calculated by PhoenixWinNonlin software (V8.0 or higher).

Trial Locations

Locations (4)

Prince of Wales Hospital; 🇨🇳 Hong Kong, China

Queen Mary Hospital; 🇨🇳 Hong Kong, China

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Clinical Trial Consultants AB; 🇸🇪 Uppsala, Sweden