A Study of RBD1016 in CHB Participants

Chronic Hepatitis b Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961098
• Other study ID #: RBHB1203
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2023
• Est. completion date: March 15, 2026

Study information

• Verified date: July 2023
• Source: Suzhou Ribo Life Science Co. Ltd.
• Contact: Jidong Jia, doctor
• Phone: 0512-57017802
• Email: jiamd[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 15, 2026
• Est. primary completion date: August 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• RBD1016
RBD1016 with NAs background treatment will be explored.
• RBD1016+PegIFN-a
RBD1016 with PegIFN-a and NAs background treatment will be explored.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm
Sweden	Clinical Trial Consultants AB	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Ribo Life Science Co. Ltd.

Country where clinical trial is conducted

Sweden, 

Outcome

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