CTIS2023-503880-40-00招募中1 期
A phase II clinical trial to evaluate the safety, efficacy, and pharmacokinetics of RBD1016 injection in participants with chronic hepatitis B - RBHB1203
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1)Willing and able to give written informed consent for trial participation;, 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;, 11)For females with child-bearing potential: must be non-pregnant and non-lactating; the participant is using a highly effective contraceptive method for at least one month before screening and agree contraception during the trial period;, 12)For males with child-bearing potential: the participant agrees contraception to ensure effective contraception for his sexual partner during the trial period., 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/plasma alanine aminotransferase (ALT) = 1.5 times the upper limit of normal (ULN);
排除标准
- •1)Laboratory results at screening as follows: serum/plasma alpha-fetoprotein (AFP) >50 µg/L; serum/plasma albumin concentration <3.0 g/dL; international normalized ratio (INR) >1.5; serum/plasma platelet count <90×109/L; serum/plasma direct bilirubin (DB) >2×ULN; serum/plasma 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 trial;, 18)Excessive alcohol drinking or abuse within 6 months before screening (for males: more than 14 standard units per week, and for females: more than 9 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits of 40 % alcohol or 150 mL of wine) which in the investigator’s opinion that it is not appropriate to participate in this trial;, 19)Drug users/drug abusers at 6 months before screening, and those who are proven to be drug abusers by reasonable evidence (at the discretion of the investigator);, 2)Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;, 20)Those who the investigator believes are not suitable to participate in the trial due to other factors., 3)Diagnosed with other liver diseases other than hepatitis B, including: autoimmune liver disease (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis), inherited metabolic liver disease (hemochromatosis, Wilson’s disease, familial intrahepatic cholestasis, etc.), drug-induced liver disease and moderate or above non-alcoholic steatohepatitis (NASH), and the investigator believes that they are not suitable to participate in this trial;, 4)History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;, 5)History of organ transplantation or hepatocellular carcinoma (HCC);, 6)History of COVID-19 within one month before screening;, 7)Any serious or active disease other than liver disease that the investigator believes may interfere with the participant’s treatment, evaluation or compliance with the trial protocol, including any uncontrolled clinically significant renal, cardiac, pulmonary, thyroid, vascular, neurogenic, digestive, and metabolic disease;, 8)History of immune-associated diseases (for example: idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, severe psoriasis, or any other autoimmune disease);, 10)Severe mental illness or uncontrolled current mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression, which makes the participant not suitable for trial participation in opinion of the investigator;, 9)History of malignant tumor within 5 years before screening, excluding special tumors cured by surgery (such as basal skin cancer);, 11)Abnormal and clinically significant 12-lead ECG test results at screening such as QTcB/QTcF male>470ms, female>480ms, or other clinically significant abnormalities, which makes the participant not suitable for trial participation in opinion of the investigator;, 12)Participants who have undergone major surgery within 6 months before screening;, 13)Participants with serious infection, trauma or surgery within 4 weeks before screening, or those
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