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

NCT02356419 | Unknown Phase 1 DMC

• 1 other identifier: SSS06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• Reticulocyte counts

  observe the reticulocyte counts and judge whether rESP could improve anemia

  6 months

Secondary Outcomes (1)

• Hemoglobin counts

  6 months

Study Arms (4)

experimental 0.5 ug/kg

EXPERIMENTAL

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

experimental 1.0ug/kg

EXPERIMENTAL

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

experimental 2.0ug/kg

EXPERIMENTAL

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

experimental 3.0ug/kg

EXPERIMENTAL

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

Interventions

Recombinant erythropoietin stimulating protein 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

Also known as: Recombinant erythropoietin stimulating protein injection

experimental 0.5 ug/kg; experimental 1.0ug/kg; experimental 2.0ug/kg; experimental 3.0ug/kg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Limei Zhao, doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Limei Zhao, doctor

CONTACT

8624-96615; zhaolm@sj-hospital.org

feng qiu, doctor

CONTACT

8624-96615; zhaolm@sj-hospital.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2015
• First Posted: February 5, 2015
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

CN (1)