Back to resultsrESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
Primary Purpose
Chronic Renal Failure
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant erythropoietin stimulating protein
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure
Eligibility Criteria
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
Sites / Locations
- Shengjing Hospital affiliated to China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
experimental 0.5 ug/kg
experimental 1.0ug/kg
experimental 2.0ug/kg
experimental 3.0ug/kg
Arm Description
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
Outcomes
Primary Outcome Measures
Reticulocyte counts
observe the reticulocyte counts and judge whether rESP could improve anemia
Secondary Outcome Measures
Hemoglobin counts
observe the hemoglobin counts and judge whether rESP could improve anemia
Full Information
NCT ID
NCT02356419
First Posted
January 18, 2015
Last Updated
February 1, 2015
Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
1. Study Identification
Unique Protocol Identification Number
NCT02356419
Brief Title
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental 0.5 ug/kg
Arm Type
Experimental
Arm Description
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
Arm Title
experimental 1.0ug/kg
Arm Type
Experimental
Arm Description
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
Arm Title
experimental 2.0ug/kg
Arm Type
Experimental
Arm Description
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
Arm Title
experimental 3.0ug/kg
Arm Type
Experimental
Arm Description
there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein
Intervention Type
Drug
Intervention Name(s)
Recombinant erythropoietin stimulating protein
Other Intervention Name(s)
Recombinant erythropoietin stimulating protein injection
Intervention Description
Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
Primary Outcome Measure Information:
Title
Reticulocyte counts
Description
observe the reticulocyte counts and judge whether rESP could improve anemia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hemoglobin counts
Description
observe the hemoglobin counts and judge whether rESP could improve anemia
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limei Zhao, doctor
Phone
8624-96615
Email
zhaolm@sj-hospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
feng qiu, doctor
Phone
8624-96615
Email
zhaolm@sj-hospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limei Zhao, doctor
Organizational Affiliation
Shengjing hospital affiliated to China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengjing Hospital affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
limei zhao, doctor
Phone
8624-96615
Email
zhaolm@sj-hospital.org
First Name & Middle Initial & Last Name & Degree
feng qiu, doctor
Phone
8624-96615
Email
zhaolm@sj-hospital.org
12. IPD Sharing Statement
Learn more about this trial
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
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