Clinical trial NCT05961098: A Study of RBD1016 in CHB Participants
Official title: A Phase II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of RBD1016 Injection in Participants with Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Suzhou Ribo Life Science Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: safety: number and percentage of AEs
timeFrame: 24 weeks
measure: efficacy: the maximum decline of HBsAg level
timeFrame: 24 weeks
Secondary outcomes:
measure: efficacy: the proportion of HBsAg decline≥1 log10 IU/mL
timeFrame: 24 weeks
measure: PK parameter Cmax
timeFrame: 12 weeks
measure: PK parameter Tmax
timeFrame: 12 weeks
measure: PK parameter AUC0-t
timeFrame: 12 weeks
measure: PK parameter t1/2
timeFrame: 12 weeks
measure: PK parameter Vd/F
timeFrame: 12 weeks
measure: PK parameter CL/F
timeFrame: 12 weeks
measure: PK parameter Css
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Clinical Trial Consultants AB
Study officials:
References: