NCT03246009

Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tianjin SinoBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Chemotherapy-induced Neutropenia
• Cancer, Breast

Interventions

Type	Name	Description
DRUG	rHSA/GCSF	single injection-1.8mg
DRUG	rHSA/GCSF	single injection-2.1mg
DRUG	rHSA/GCSF	single injection-2.4mg
DRUG	rHSA/GCSF	multiple injection-1.8mg
DRUG	rHSA/GCSF	multiple injection-2.1mg
DRUG	rHSA/GCSF	multiple injection-2.4mg

Timeline

• Start date: 2016-01-21
• Primary completion: 2017-04-10
• Completion: 2017-04-10
• First posted: 2017-08-10
• Last updated: 2017-08-11

Locations

1 site across 1 country: China