drugset / Trial / NCT03246009

Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

NCT03246009 ↗

Phase 1 Completed 24 enrolled Tianjin SinoBiotech Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2016-01-21
Primary completion
2017-04-10
Completion
2017-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject rHSA/GCSF Protein / enzyme biologic 1.8 mg Subcutaneous
Subject rHSA/GCSF Protein / enzyme biologic 2.1 mg Subcutaneous
Subject rHSA/GCSF Protein / enzyme biologic 2.4 mg Subcutaneous