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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Drug: Recombinant erythropoietin stimulating protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental 0.5 ug/kg<br>there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein | Drug: Recombinant erythropoietin stimulating protein<br>* Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites<br>* Other names: Recombinant erythropoietin stimulating protein injection;|
| Experimental: experimental 1.0ug/kg<br>there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein | Drug: Recombinant erythropoietin stimulating protein<br>* Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites<br>* Other names: Recombinant erythropoietin stimulating protein injection;|
| Experimental: experimental 2.0ug/kg<br>there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein | Drug: Recombinant erythropoietin stimulating protein<br>* Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites<br>* Other names: Recombinant erythropoietin stimulating protein injection;|
| Experimental: experimental 3.0ug/kg<br>there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein | Drug: Recombinant erythropoietin stimulating protein<br>* Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites<br>* Other names: Recombinant erythropoietin stimulating protein injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reticulocyte counts | observe the reticulocyte counts and judge whether rESP could improve anemia | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin counts | observe the hemoglobin counts and judge whether rESP could improve anemia | 6 months |