A Phase II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of RBD1016 Injection in Participants With Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- safety: number and percentage of AEs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •HBV DNA level <100 IU/mL at screening;
- •HBsAg level ≥50 IU/mL at screening;
- •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;
排除标准
- •Diagnosed with other liver diseases other than hepatitis B;
- •History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
- •History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
- •Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
- •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;
- •Those who the investigator believes are not suitable to participate in the study due to other factors.
研究组 & 干预措施
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.
干预措施: RBD1016 (Drug)
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.
干预措施: RBD1016 (Drug)
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.
干预措施: RBD1016 (Drug)
结局指标
主要结局
safety: number and percentage of AEs
时间窗: 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
时间窗: 24 weeks
The maximum decline (log value) of HBsAg level. Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
次要结局
- efficacy: the proportion of HBsAg decline≥1 log10 IU/mL(24 weeks)
- PK parameter Cmax(12 weeks)
- PK parameter Tmax(12 weeks)
- PK parameter AUC0-t(12 weeks)
- PK parameter t1/2(12 weeks)
- PK parameter Vd/F(12 weeks)
- PK parameter CL/F(12 weeks)
- PK parameter Css(12 weeks)