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

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02356419
• Other study ID #: SSS06
• Status: Recruiting
• Phase: Phase 1
• First received: January 18, 2015
• Last updated: February 1, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Contact: Limei Zhao, doctor
• Phone: 8624-96615
• Email: zhaolm[@]sj-hospital.org
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Sunshine Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reticulocyte counts	observe the reticulocyte counts and judge whether rESP could improve anemia	6 months	Yes
Secondary	Hemoglobin counts	observe the hemoglobin counts and judge whether rESP could improve anemia	6 months	Yes