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

Healthy Subjects Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03786289
Study type Interventional
Source Tianjin SinoBiotech Ltd.
Contact
Status Completed
Phase Phase 1
Start date December 3, 2018
Completion date December 9, 2019
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