Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients

Phase 1 Completed 30 enrolled Xiamen Amoytop Biotech Co., Ltd. Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collab

RandomizedCrossoverOpen-label

Summary

This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).

Timeline

Start: 2010-04
Primary completion: 2011-11
Completion: 2011-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	YPEG-Filgrastim	Unknown	10 ug/kg	Subcutaneous
Subject	YPEG-Filgrastim	Unknown	20 ug/kg	Subcutaneous
Subject	YPEG-Filgrastim	Unknown	30 ug/kg	Subcutaneous
Subject	YPEG-Filgrastim	Unknown	45 ug/kg	Subcutaneous
Subject	YPEG-Filgrastim	Unknown	60 ug/kg	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	2.5 ug/kg	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	5 ug/kg	Subcutaneous

Indications

No indication recorded.