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

February 1, 2015 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital Affiliated to China Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reticulocyte counts
Time Frame: 6 months
observe the reticulocyte counts and judge whether rESP could improve anemia
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin counts
Time Frame: 6 months
observe the hemoglobin counts and judge whether rESP could improve anemia
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Sunshine Pharmaceutical Co., LTD.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Limei Zhao, doctor, Shengjing Hospital Affiliated to China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSS06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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