drugset
drugset / Trial / NCT02725606

Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

NCT02725606 ↗

Phase 1 Unknown 30 enrolled Jiangsu T-Mab Biopharma Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.

Timeline

Start
2016-03
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GW003 Protein / enzyme biologic 300 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 650 ug/kg Subcutaneous
Subject GW003 Protein / enzyme biologic 850 ug/kg Subcutaneous
Comparator Pegylated Recombinant Human G-CSF Unknown 100 ug/kg Subcutaneous

Indications

neutropenia