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

NCT ID: NCT02356419

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Recombinant erythropoietin stimulating protein

Intervention Type: DRUG

Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

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

Group Type: EXPERIMENTAL

Recombinant erythropoietin stimulating protein

Intervention Type: DRUG

Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

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

Group Type: EXPERIMENTAL

Recombinant erythropoietin stimulating protein

Intervention Type: DRUG

Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

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

Group Type: EXPERIMENTAL

Recombinant erythropoietin stimulating protein

Intervention Type: DRUG

Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Recombinant erythropoietin stimulating protein injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Limei Zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Limei Zhao, doctor

Role: CONTACT

zhaolm@sj-hospital.org

8624-96615

feng qiu, doctor

Role: CONTACT

zhaolm@sj-hospital.org

8624-96615

Facility Contacts

limei zhao, doctor

Role: primary

zhaolm@sj-hospital.org

8624-96615

feng qiu, doctor

Role: backup

zhaolm@sj-hospital.org

8624-96615

Other Identifiers

SSS06

Identifier Type: -

Identifier Source: org_study_id