rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
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.
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.
Inclusion Criteria:

 1. Aged 18-40 years old, male or female

 2. Subjects are previously healthy, and whose physical examinations are normal 14 days
 ago before the screening examination

 3. The BMI is 19-25Kg/m2 (BMI = weight / height2)

 4. Without anemia, white blood cell and platelet counts are normal

 5. Heart, lung, liver and kidney function are normal

 6. Without smoke and wine hobby

 7. Subjects voluntarily signing written informed consent.

 Exclusion Criteria:

 1. Allergic constitution or previous history of allergy of biological products;

 2. Pregnant and lactating women;

 3. 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;

 4. Female subjects received postmenopausal estrogen therapy;

 5. With malignant hypertension or hypertension is poorly controlled or with previous
 history of thromboembolic diseases and diseases of hematopoietic system

 6. Abnormal liver function ( AST or ALT is 2 times greater than the upper limit of the
 normal)

 7. Hemoglobin is greater than or equal to 160g/L (male), 150 g/L (female)

 8. The percentage of reticulocytes is greater than or equal to 3%

 9. Serum iron protein <20ng/ml

 10. Subjects who donated blood 90 days before being enrolled or received a blood
 transfusion therapy or participate in other drug test

 11. subjects who received recombinant erythropoiesis stimulating protein or rHuEPO 3
 months before being enrolled;

 12. recombinant erythropoiesis stimulating protein antibody (RESP) or endogenous
 erythropoietin (EPO) antibody positive;

 13. drugs known to have damage to some organs were given 3 months before being enrolled;

 14. subjects whose HBsAg, HBeAg, anti-HIV, anti-HCV and syphilis antibody are positive;

 15. researchers believe that other factors are not suitable for the trial