<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786289</url>
  </required_header>
  <id_info>
    <org_study_id>1882-I</org_study_id>
    <nct_id>NCT03786289</nct_id>
  </id_info>
  <brief_title>Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection</brief_title>
  <official_title>Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin SinoBiotech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin SinoBiotech Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to&#xD;
      investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to&#xD;
      obtain preliminary pharmacokinetic parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This experiment was a single-center clinical study with randomized, open, positive drug&#xD;
      control and single dose increment. The test group will be conducted in the order of&#xD;
      incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO).&#xD;
      After 7 days of administration, the researchers looked at the drug safety tolerance of the&#xD;
      test to determine whether to proceed with the next higher dose group test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">July 3, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>Incidence of adverse events, adverse reactions and serious adverse events after single administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of recombinant human erythropoietin injection (Cho cell) in serum</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erythrocyte count,before and after administration</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin,before and after administration</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the percentage of erythrocyte red blood cells,before and after administration</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>erythrocyte ratio (HCT) before and after administration</measure>
    <time_frame>Day1-Day29</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Recombinant human serum albumin/erythropoietin fusion protein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recombinant human erythropoietin injection (CHO cells)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant human serum albumin/erythropoietin fusion protein</intervention_name>
    <description>Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1</description>
    <arm_group_label>Recombinant human serum albumin/erythropoietin fusion protein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant erythropoietin injection (CHO cells)</intervention_name>
    <description>Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1</description>
    <arm_group_label>Recombinant human erythropoietin injection (CHO cells)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) in the range of 19.0~26.0 (including critical value) (bmi= bw&#xD;
             (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg&#xD;
&#xD;
          -  Understand and sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Persons with allergic physique or sensitive skin;&#xD;
&#xD;
          2. Any person with any skin disease;&#xD;
&#xD;
          3. have a history of drug or food allergies, especially for the active ingredients of&#xD;
             this product or similar drugs, mammalian cells to The source of the drug, human serum&#xD;
             albumin or other biological agents expressed in CHO allergy;&#xD;
&#xD;
          4. Pre-Test medical history, vital signs, physical examination, laboratory examination&#xD;
             and other relevant examinations during the screening period, Abnormal and clinically&#xD;
             significant person;&#xD;
&#xD;
          5. Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves,&#xD;
             autoimmune, metabolic and skeletal muscle system, hematopoietic system and other&#xD;
             diseases of history;&#xD;
&#xD;
          6. Having a fertility plan within 2 weeks of screening and within 6 months of the end of&#xD;
             the trial and not having to take it during the trial period&#xD;
&#xD;
             (a) Effective non-drug contraceptive measures;&#xD;
&#xD;
          7. Within 14 days prior to screening or within 5 half-life of the drug (whichever is the&#xD;
             oldest of the two) there has been any Prescription drugs, over-the-counter drugs,&#xD;
             Chinese herbal medicine, health care products medicine history;&#xD;
&#xD;
          8. Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version&#xD;
             number: 1.2 Version date: September 30, 2018 26 sexual);&#xD;
&#xD;
          9. The percentage of erythrocyte red blood cells ≥ 3%;&#xD;
&#xD;
         10. ferritin &lt;200 ng/ml (male), ferritin &lt;80 ng/ml (female);&#xD;
&#xD;
         11. The use of drugs known to have damage to an organ during the first 3 months of&#xD;
             screening;&#xD;
&#xD;
         12. A person who has received a blood transfusion or rhEPO treatment;&#xD;
&#xD;
         13. Clinically determined to be vitamin B12 or folic acid deficiency;&#xD;
&#xD;
         14. Have a history of dizziness and needle sickness;&#xD;
&#xD;
         15. A clinical trial person who has participated in other drugs within the first 3 months&#xD;
             of screening;&#xD;
&#xD;
         16. Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;&#xD;
&#xD;
         17. Women during pregnancy and lactation;&#xD;
&#xD;
         18. The researchers did not consider it appropriate to enter the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing you 'an hospital affiliated to capital medical university</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Recombinant human erythropoietin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786289
org study id: 1882-I
nct id: NCT03786289
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: Day1-Day29
description: Incidence of adverse events, adverse reactions and serious adverse events after single administration
measure: Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum
time frame: Day1-Day29
description: 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.
measure: Concentration of recombinant human erythropoietin injection (Cho cell) in serum
time frame: Day1-Day29
description: 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.
measure: Erythrocyte count,before and after administration
time frame: Day1-Day29
description: 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.
measure: hemoglobin,before and after administration
time frame: Day1-Day29
description: 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.
measure: the percentage of erythrocyte red blood cells,before and after administration
time frame: Day1-Day29
description: 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.
measure: erythrocyte ratio (HCT) before and after administration
time frame: Day1-Day29
description: 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.
arm group label: Recombinant human serum albumin/erythropoietin fusion protein
arm group type: Experimental
description: Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection
arm group label: Recombinant human erythropoietin injection (CHO cells)
arm group type: Active Comparator
description: Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection
intervention type: Biological
intervention name: Recombinant human serum albumin/erythropoietin fusion protein
description: Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1
arm group label: Recombinant human serum albumin/erythropoietin fusion protein
intervention type: Biological
intervention name: Recombinant erythropoietin injection (CHO cells)
description: Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1
arm group label: Recombinant human erythropoietin injection (CHO cells)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Epoetin Alfa