Chronic kidney disease with Anaemia
Conditions
Interventions
0.1ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
0.25 ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
0.50ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
1.00ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
1.50ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
2.00ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
2.50ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
3.00ug/Kg subcutaneous infusion group:Single dose of study drug through subcutaneous infusion
2.00ug/Kg intravenous infusion group:Single dose of study drug through intravenous infusion
2.50ug/Kg intravenous infusion group:Single dose of study drug through intravenous infusion
3.00ug/Kg intravenous infusion group:Single dose of study drug through intravenous infusion
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-40, male or female; 2) Always health good, physical examination within 14 days before screening is normal; 3) Body mass index in 19-25Kg/m2 (BMI=weight/height2); 4) Without anemia, white blood cell and platelet counts is normal; 5) The function of heart, lung, liver, kidney is normal; 6) No addiction of tobacco or alcohol; 7) Voluntarily signed on informed consent form.
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis or allergy to biological drug; 2) Subjects who are pregnant or nursing a child; 3) Female subjects only take oral contraceptive, and are planning pregnancy during the study or within 3 months post administration; 4) Male subjects, whose female partner is planning pregnancy during the study or within 3 months post administration; 5) Female subjects receiving estrogen therapy after menopause; 6) Subjects with malignant hypertension or poor hypertension control, or having a history of thromboembolic disease or hematopoietic system disease; 7) HB >=150g/L; 8) Reticulocyte>=3%; 9) serum ferritin <20ng/ml; 10) Donated bloodreceived a blood transfusion treatment or participated in other drug study within 90 days of inclusion; 11) Subjects who have received recombinant erythropoiesis stimulating protein or rHuEPO treatment within 3 months of inclusion; 12) Positive result of recombinant erythropoiesis stimulating protein antibody ( RESP ) or endogenous erythropoietin (EPO) antibody test; 13) Subjects who have taken organs damage drug known by now within 3 months of inclusion; 14) Subjects with positive results of the following serological tests: HBsAg, HBeAg, anti-HIV, anti-HCV, treponema pallidum antibody; 15) Subjects who in the opinion of the investigator are unsuitable for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine hematology;Biochemistry;Liver and kidney function test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination;Chest X-ray detection;Coagulation test;Urinalysis;Recombinant erythropoiesis stimulating protein antibody;Endogenous erythropoietin antibody detection;Serum ferritin;Reticulocyte count;RESP blood concentration; | — |
Countries
China
Contacts
Public ContactMei Changlin
Outcome results
None listed