Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose & Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
研究概览
简要总结
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
详细描述
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBV patients who have positive HBeAg or HBeAb
- •Must be healthy males or females between 18 to 60 years old
- •Must have a body mass index (BMI) of 18 to 30 kg/m2
- •HBV DNA≥2000 IU/mL
- •ALT≥1.3 ULN and ≤10 ULN
排除标准
- •* Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus drugs, immunosuppressants, immune regulator before 6 months;Or any other against hepatitis b virus therapy at the same time.
- •* Participated in other clinical trials within a month.
- •* Allergic to interferon.
- •* T-Bil ≥2 ULN. ALB\<35g/L. PT≥4s.
- •* Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab.
- •* Organ transplant patients, except cornea or hair transplantation.
- •* Other hepatopathy exclude NAFLD .
- •* Drug addiction or alcohol dependence.
- •* Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma) except liver history.
- •* Serious retinal disease.
- •* Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation disorder.
- •* Autoimmune disease.
- •* Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure.
- •* WBC\<3×109/L or ANC\<1.5 ×109/L or PLT\<90 ×109/L or HGB\100ng/mL.
- •* Chronic kidney disease or sCr\>ULN.
- •* Lactating women or pregnancy.
- •* Cardiovascular and cerebrovascular events within 6 months.
- •* Neurological or psychiatric disease or family history.
结局指标
主要结局
the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
时间窗: 17 weeks
HBV DNA
次要结局
- the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment(4 weeks and 17 weeks)
- the recovery rates of ALT after treatment(17 weeks)
- the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment(17 weeks)
- the rates of HBsAg decrease from baseline after treatment(17 weeks)