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

NCT03786289 | Completed Phase 1

• 1 other identifier: 1882-I
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Recombinant human erythropoietin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum

  Day1-Day29

• Concentration of recombinant human erythropoietin injection (Cho cell) in serum

  Day1-Day29

• Erythrocyte count,before and after administration

  Day1-Day29

• hemoglobin,before and after administration

  Day1-Day29

• the percentage of erythrocyte red blood cells,before and after administration

  Day1-Day29

Study Arms (2)

Recombinant human serum albumin/erythropoietin fusion protein

EXPERIMENTAL

Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection

Biological: Recombinant human serum albumin/erythropoietin fusion protein

Recombinant human erythropoietin injection (CHO cells)

ACTIVE COMPARATOR

Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection

Biological: Recombinant erythropoietin injection (CHO cells)

Interventions

Recombinant human serum albumin/erythropoietin fusion protein BIOLOGICAL

Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1

Recombinant human serum albumin/erythropoietin fusion protein

Recombinant erythropoietin injection (CHO cells) BIOLOGICAL

Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1

Recombinant human erythropoietin injection (CHO cells)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Persons with allergic physique or sensitive skin;
• Any person with any skin disease;
• 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;
• Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
• Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
• 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;
• 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;
• 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);
• The percentage of erythrocyte red blood cells ≥ 3%;
• ferritin \<200 ng/ml (male), ferritin \<80 ng/ml (female);
• The use of drugs known to have damage to an organ during the first 3 months of screening;
• A person who has received a blood transfusion or rhEPO treatment;
• Clinically determined to be vitamin B12 or folic acid deficiency;
• Have a history of dizziness and needle sickness;

Sponsors & Collaborators

• Tianjin SinoBiotech Ltd.: lead

Study Sites (1)

Beijing you 'an hospital affiliated to capital medical university

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 26, 2018
• Study Start: December 3, 2018
• Primary Completion: July 3, 2019
• Study Completion: December 9, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

CN (1)