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

Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: Recombinant human serum albumin/erythropoietin fusion protein; Biological: Recombinant erythropoietin injection (CHO cells)

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: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing you 'an hospital affiliated to capital medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of adverse events, adverse reactions and serious adverse events after single administration	Day1-Day29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum	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.	Day1-Day29
Concentration of recombinant human erythropoietin injection (Cho cell) in serum	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.	Day1-Day29
Erythrocyte count,before and after administration	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.	Day1-Day29
hemoglobin,before and after administration	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.	Day1-Day29
the percentage of erythrocyte red blood cells,before and after administration	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.	Day1-Day29
erythrocyte ratio (HCT) before and after administration	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.	Day1-Day29

Collaborators and Investigators

• Sponsor: Tianjin SinoBiotech Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2018
• Primary Completion (ACTUAL): July 3, 2019
• Study Completion (ACTUAL): December 9, 2019

Study Registration Dates

• First Submitted: December 16, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (ACTUAL): December 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Recombinant human erythropoietin
• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: 1882-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No