Clinical trial NCT02356419: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Renal Failure
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reticulocyte counts
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin counts
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Limei Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
References: