A Study of RBD1016 in CHB Participants

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

This study consists of Part A and Part B. Part A is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with NAs in CHB participants. Part B is a multi-center, open clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with PegIFN-α and NAs in CHB participants.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: RBD1016; Drug: RBD1016+PegIFN-α

Detailed Description

The study consists of screening period, treatment period, and follow up period. Part A is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 28 eligible participants, with 21 participants receiving RBD1016 injection and 7 participants receiving placebo. Part B has a RBD1016 200mg dose group, which will enroll 20 participants to receive RBD1016 combined with PegIFN-α and NAs treatment.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jidong Jia, doctor; Phone Number: 0512-57017805 0512-57017802; Email: jiamd@263.net
• Study Contact Backup: Name: Jidong Jia; Phone Number: 0512-57017802

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Recruiting
    • Karolinska University Hospital
    • Contact: Olsson; Email: annika.el.olsson@regionstockholm.se
    • Principal Investigator: Soo Aleman
  • Uppsala, Sweden, 752 37
    • Not yet recruiting
    • Clinical Trial Consultants AB
    • Contact: Lidström; Email: malte.lidstrom@ctc-ab.se

Participation Criteria

Eligibility Criteria

• 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. Serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN);
8. 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.

Additional exclusion criteria for Part B:

1. Participants who are judged not to be suitable for IFN treatment for any reason;
2. History of IFN treatment within 12 months prior to screening;
3. Other situations that the investigator believes are not suitable to participate in Part B.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: RBD1016+PegIFN-α 200 mg Q4W group; Participants in the 200 mg Q4W dose group will receive corresponding doses of RBD1016 injection by subcutaneous injection on D1, D29, D57, and D85, and also receive 180 µg PegIFN-α subcutaneously every week for 48 weeks	Drug: RBD1016+PegIFN-α; RBD1016 with PegIFN-α and NAs background treatment will be explored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks
PK parameter Cmax	Maximum concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).	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.	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).	12 weeks
PK parameter t1/2	Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).	12 weeks
PK parameter Vd/F	Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).	12 weeks
PK parameter CL/F	Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).	12 weeks

Collaborators and Investigators

• Sponsor: Suzhou Ribo Life Science Co. Ltd.
• Investigators: Principal Investigator: Jidong Jia, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): August 21, 2025
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID 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