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 for Healthy Subjects in the Phase Ⅰ Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Drug: Recombinant erythropoietin stimulating protein

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: limei zhao, doctor; Phone Number: 8624-96615; Email: zhaolm@sj-hospital.org
• Study Contact Backup: Name: feng qiu, doctor; Phone Number: 8624-96615; Email: zhaolm@sj-hospital.org

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital affiliated to China Medical University
      • Contact: limei zhao, doctor; Phone Number: 8624-96615; Email: zhaolm@sj-hospital.org
      • Contact: feng qiu, doctor; Phone Number: 8624-96615; Email: zhaolm@sj-hospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Recombinant erythropoietin stimulating protein; Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites; Other Names: Recombinant erythropoietin stimulating protein injection
Experimental: 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	Drug: Recombinant erythropoietin stimulating protein; Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites; Other Names: Recombinant erythropoietin stimulating protein injection
Experimental: 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	Drug: Recombinant erythropoietin stimulating protein; Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites; Other Names: Recombinant erythropoietin stimulating protein injection
Experimental: 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	Drug: Recombinant erythropoietin stimulating protein; Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites; Other Names: Recombinant erythropoietin stimulating protein injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
• Investigators: Principal Investigator: Limei Zhao, doctor, Shengjing Hospital affiliated to China Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: January 18, 2015
• First Submitted That Met QC Criteria: February 1, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 1, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hematinics; Epoetin Alfa
• Other Study ID Numbers: SSS06