rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics for Healthy Subjects in the Phase Ⅰ Clinical Study
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reticulocyte counts
研究概览
简要总结
The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
详细描述
The study is a single center and open test, and the dose of successive incremental method was taken. The study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40 years old, male or female
- •Subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination
- •The BMI is 19-25Kg/m2 (BMI = weight / height2)
- •Without anemia, white blood cell and platelet counts are normal
- •Heart, lung, liver and kidney function are normal
- •Without smoke and wine hobby
- •Subjects voluntarily signing written informed consent.
排除标准
- •Allergic constitution or previous history of allergy of biological products;
- •Pregnant and lactating women;
- •Female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration;
- •Female subjects received postmenopausal estrogen therapy;
- •With malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system
- •Abnormal liver function ( AST or ALT is 2 times greater than the upper limit of the normal)
- •Hemoglobin is greater than or equal to 160g/L (male), 150 g/L (female)
- •The percentage of reticulocytes is greater than or equal to 3%
- •Serum iron protein <20ng/ml
- •Subjects who donated blood 90 days before being enrolled or received a blood transfusion therapy or participate in other drug test
- •subjects who received recombinant erythropoiesis stimulating protein or rHuEPO 3 months before being enrolled;
- •recombinant erythropoiesis stimulating protein antibody (RESP) or endogenous erythropoietin (EPO) antibody positive;
- •drugs known to have damage to some organs were given 3 months before being enrolled;
- •subjects whose HBsAg, HBeAg, anti-HIV, anti-HCV and syphilis antibody are positive;
- •researchers believe that other factors are not suitable for the trial
研究组 & 干预措施
experimental 0.5 ug/kg
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
干预措施: Recombinant erythropoietin stimulating protein (Drug)
experimental 1.0ug/kg
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
干预措施: Recombinant erythropoietin stimulating protein (Drug)
experimental 2.0ug/kg
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
干预措施: Recombinant erythropoietin stimulating protein (Drug)
experimental 3.0ug/kg
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
干预措施: Recombinant erythropoietin stimulating protein (Drug)
结局指标
主要结局
Reticulocyte counts
时间窗: 6 months
observe the reticulocyte counts and judge whether rESP could improve anemia
次要结局
- Hemoglobin counts(6 months)