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

NCT ID: NCT03786289

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2019-12-09

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recombinant human serum albumin/erythropoietin fusion protein

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

Group Type: EXPERIMENTAL

Recombinant human serum albumin/erythropoietin fusion protein

Intervention Type: BIOLOGICAL

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

Recombinant human erythropoietin injection (CHO cells)

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

Group Type: ACTIVE_COMPARATOR

Recombinant erythropoietin injection (CHO cells)

Intervention Type: BIOLOGICAL

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

Interventions

Recombinant human serum albumin/erythropoietin fusion protein

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

Intervention Type: BIOLOGICAL

Recombinant erythropoietin injection (CHO cells)

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin SinoBiotech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing you 'an hospital affiliated to capital medical university

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

1882-I

Identifier Type: -

Identifier Source: org_study_id