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Clinical Trial Summary

The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.

To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration


Clinical Trial Description

This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.

Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.

The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.

Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03246009
Study type Interventional
Source Tianjin SinoBiotech Ltd.
Contact
Status Completed
Phase Phase 1
Start date January 21, 2016
Completion date April 10, 2017

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