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Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection

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ClinicalTrials.gov Identifier: NCT03786289
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

Brief Summary:
The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters.

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: Recombinant human serum albumin/erythropoietin fusion protein Biological: Recombinant erythropoietin injection (CHO cells) Phase 1

Detailed Description:
This experiment was a single-center clinical study with randomized, open, positive drug control and single dose increment. The test group will be conducted in the order of incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO). After 7 days of administration, the researchers looked at the drug safety tolerance of the test to determine whether to proceed with the next higher dose group test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Recombinant human serum albumin/erythropoietin fusion protein
Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection
Biological: Recombinant human serum albumin/erythropoietin fusion protein
Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1

Active Comparator: Recombinant human erythropoietin injection (CHO cells)
Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection
Biological: Recombinant erythropoietin injection (CHO cells)
Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day1-Day29 ]
    Incidence of adverse events, adverse reactions and serious adverse events after single administration


Secondary Outcome Measures :
  1. Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures drug concentrations.

  2. Concentration of recombinant human erythropoietin injection (Cho cell) in serum [ Time Frame: Day1-Day29 ]
    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures drug concentrations.

  3. Erythrocyte count,before and after administration [ Time Frame: Day1-Day29 ]

    Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures red blood cell counts.

    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures red blood cell counts.


  4. hemoglobin,before and after administration [ Time Frame: Day1-Day29 ]

    Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures hemoglobin concentrations.

    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures hemoglobin concentrations.


  5. the percentage of erythrocyte red blood cells,before and after administration [ Time Frame: Day1-Day29 ]

    Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures the percentage of erythrocyte red blood cells.

    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures the percentage of erythrocyte red blood cells.


  6. erythrocyte ratio (HCT) before and after administration [ Time Frame: Day1-Day29 ]

    Rhsa/epo: Before administration, after administration 1h,2h,6h,12h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures blood cell accumulations.

    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1h,2h,6h,9h,12h,18h,24h(2nd day), 36h(2nd day), 48h(3rd day), 72h(4th day), 96h(5th day), 120h( Day 6th), 168h(day 8th), 336h(Day 15th), 504h(22nd days) and 672h (29th days) Blood collection measures blood cell accumulations.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) in the range of 19.0~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
  • Understand and sign the informed consent form

Exclusion Criteria:

  1. Persons with allergic physique or sensitive skin;
  2. Any person with any skin disease;
  3. have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
  4. Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
  5. Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
  6. Having a fertility plan within 2 weeks of screening and within 6 months of the end of the trial and not having to take it during the trial period

    (a) Effective non-drug contraceptive measures;

  7. Within 14 days prior to screening or within 5 half-life of the drug (whichever is the oldest of the two) there has been any Prescription drugs, over-the-counter drugs, Chinese herbal medicine, health care products medicine history;
  8. Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version number: 1.2 Version date: September 30, 2018 26 sexual);
  9. The percentage of erythrocyte red blood cells ≥ 3%;
  10. ferritin <200 ng/ml (male), ferritin <80 ng/ml (female);
  11. The use of drugs known to have damage to an organ during the first 3 months of screening;
  12. A person who has received a blood transfusion or rhEPO treatment;
  13. Clinically determined to be vitamin B12 or folic acid deficiency;
  14. Have a history of dizziness and needle sickness;
  15. A clinical trial person who has participated in other drugs within the first 3 months of screening;
  16. Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;
  17. Women during pregnancy and lactation;
  18. The researchers did not consider it appropriate to enter the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786289


Contacts
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Contact: meixia wang, professor +86-010-83997181 wangmeixiad@163.com
Contact: zailin yu, professor +86 13701014142 yuzailin88@sina.com

Locations
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China, Beijing
Beijing you 'an hospital affiliated to capital medical university Recruiting
Beijing, Beijing, China, 100069
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.

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Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT03786289     History of Changes
Other Study ID Numbers: 1882-I
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin SinoBiotech Ltd.:
Recombinant human erythropoietin

Additional relevant MeSH terms:
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Epoetin Alfa
Hematinics