A Study of RBD1016 in CHB Participants
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
-
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.
Exclusion Criteria:
-
Diagnosed with other liver diseases other than hepatitis B;
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History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
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History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
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Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
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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;
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Those who the investigator believes are not suitable to participate in the study due to other factors.
Additional exclusion criteria for Part B:
-
Participants who are judged not to be suitable for IFN treatment for any reason;
-
History of IFN treatment within 12 months prior to screening;
-
Other situations that the investigator believes are not suitable to participate in Part B.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Suzhou Ribo Life Science Co. Ltd.
Investigators
- Principal Investigator: Jidong Jia, Beijing Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RBHB1203