Phase Ib/II: Multicenter, Open, Dose-escalation Evaluation of the Safety and Efficacy of STSG-0002 Injection in Patients With Chronic Hepatitis B Treated With Oral Antiviral Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Number of subjects of Significant Abnormal Vital Signs Findings
研究概览
简要总结
This trial is a multi-center, open, single-dose, dose-increasing trial，to evaluate the safety and efficacy of STSG-0002 injection in patients with chronic hepatitis B treated with oral antiviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with chronic HBV；
- •Receiving anti-HB viral therapy;
- •10 IU/ml≤HBsAg≤3000 IU/ml.
排除标准
- •Patients co-infected with hepatitis C virus, HIV, HAV, HDV, HEV;
- •Liver cirrhosis;
- •Hepatocellular carcinoma;
- •Autoimmune liver disease;
- •Clinical hepatic decompensation;
- •Fibroscan>12 kPa;
- •a. hemoglobin<110g/L（female）<120 g/L（male），platelet<ULN，white blood cell<2.5×109/L；b. bilirubin>1.5 ×ULN，ALT>2 × ULN，serum albumin<35 g/L；c. INR>1.5；d. serum creatinine >1.5×ULN.
研究组 & 干预措施
lowest dose treatment group
Subjects will receive one single lowest dose of STSG-0002 Injection following protocol requirements
干预措施: STSG-0002 Injection (Drug)
low dose treatment group
Subjects will receive one single low dose of STSG-0002 Injection following protocol requirements
干预措施: STSG-0002 Injection (Drug)
Intermediate dose treatment group
Subjects will receive one single intermediate dose of STSG-0002 Injection following protocol requirements
干预措施: STSG-0002 Injection (Drug)
A single high dose of treatment group
Subjects will receive one single high dose of STSG-0002 Injection following protocol requirements
干预措施: STSG-0002 Injection (Drug)
结局指标
主要结局
Number of subjects of Significant Abnormal Vital Signs Findings
时间窗: Baseline to Day 180
Number of Participants With Significant Abnormal Laboratory Values
时间窗: Baseline to Day 180
Number of subjects With Significant Abnormal Physical Examination
时间窗: Baseline to Day 180
Number of subjects With Significant Abnormal Electrocardiography (ECG) Findings
时间窗: Baseline to Day 180
Number of subjects of adverse events
时间窗: Baseline to Day 180
次要结局
未报告次要终点