NCT03786289

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-07-03
• Completion: 2019-12-09
• First posted: 2018-12-26
• Last updated: 2020-10-08

Locations

1 site across 1 country: China