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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 : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.

Tracking Information
First Submitted Date  ICMJE December 16, 2018
First Posted Date  ICMJE December 25, 2018
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE December 3, 2018
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03786289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 25, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Concentration of recombinant human serum albumin/erythrocyte fusion protein and recombinant human erythropoietin injection (Cho cell) in serum [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1 H, 2 H, 6 H, H, H (2nd day), H (2nd day), H (3rd day), A/h (4th day), H (5th day), A/h ( Day 6th), 168 H (day 8th), 336 H (Day 15th), 504 H (22nd days) and 672 h (29th days) Blood collection measurements.
  • Concentration of recombinant human erythropoietin injection (Cho cell) in serum [ Time Frame: Day1-Day29 ]
    Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1 H, 2 H, 6 H, 9h, H, 18h, H (2nd day), A/h (2nd day), A/h (3rd day), A (4th) H ( Day 5th), (day 6th), 168 H (day 8th), 336h (15th days), 504 H (22nd day) and 672 H (29th day) Blood collection measurements.
  • Erythrocyte count,before and after administration [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1 H, 2 H, 6 H, H, H (2nd day), H (2nd day), H (3rd day), A/h (4th day), H (5th day), A/h ( Day 6th), 168 H (day 8th), 336 H (Day 15th), 504 H (22nd days) and 672 h (29th days) Blood collection measurements. Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1 H, 2 H, 6 H, 9h, H, 18h, H (2nd day), A/h (2nd day), A/h (3rd day), A (4th) H ( Day 5th), (day 6th), 168 H (day 8th), 336h (15th days), 504 H (22nd day) and 672 H (29th day) Blood collection measurements.
  • hemoglobin,before and after administration [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1 H, 2 H, 6 H, H, H (2nd day), H (2nd day), H (3rd day), A/h (4th day), H (5th day), A/h ( Day 6th), 168 H (day 8th), 336 H (Day 15th), 504 H (22nd days) and 672 h (29th days) Blood collection measurements. Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1 H, 2 H, 6 H, 9h, H, 18h, H (2nd day), A/h (2nd day), A/h (3rd day), A (4th) H ( Day 5th), (day 6th), 168 H (day 8th), 336h (15th days), 504 H (22nd day) and 672 H (29th day) Blood collection measurements.
  • the percentage of erythrocyte red blood cells,before and after administration [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1 H, 2 H, 6 H, H, H (2nd day), H (2nd day), H (3rd day), A/h (4th day), H (5th day), A/h ( Day 6th), 168 H (day 8th), 336 H (Day 15th), 504 H (22nd days) and 672 h (29th days) Blood collection measurements. Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1 H, 2 H, 6 H, 9h, H, 18h, H (2nd day), A/h (2nd day), A/h (3rd day), A (4th) H ( Day 5th), (day 6th), 168 H (day 8th), 336h (15th days), 504 H (22nd day) and 672 H (29th day) Blood collection measurements.
  • erythrocyte ratio (HCT) before and after administration [ Time Frame: Day1-Day29 ]
    Rhsa/epo: Before administration, after administration 1 H, 2 H, 6 H, H, H (2nd day), H (2nd day), H (3rd day), A/h (4th day), H (5th day), A/h ( Day 6th), 168 H (day 8th), 336 H (Day 15th), 504 H (22nd days) and 672 h (29th days) Blood collection measurements. Recombinant human erythropoietin injection (Cho cells): Before and after administration, 1 H, 2 H, 6 H, 9h, H, 18h, H (2nd day), A/h (2nd day), A/h (3rd day), A (4th) H ( Day 5th), (day 6th), 168 H (day 8th), 336h (15th days), 504 H (22nd day) and 672 H (29th day) Blood collection measurements.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection
Official Title  ICMJE Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Biological: Recombinant human serum albumin/erythropoietin fusion protein
    Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1
  • Biological: Recombinant erythropoietin injection (CHO cells)
    Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1
Study Arms  ICMJE
  • Experimental: Recombinant human serum albumin/erythropoietin fusion protein
    Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection
    Intervention: Biological: Recombinant human serum albumin/erythropoietin fusion protein
  • Active Comparator: Recombinant human erythropoietin injection (CHO cells)
    Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection
    Intervention: Biological: Recombinant erythropoietin injection (CHO cells)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date July 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: meixia wang, professor +86-010-83997181 wangmeixiad@163.com
Contact: zailin yu, professor +86 13701014142 yuzailin88@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03786289
Other Study ID Numbers  ICMJE 1882-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tianjin SinoBiotech Ltd.
Study Sponsor  ICMJE Tianjin SinoBiotech Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tianjin SinoBiotech Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP