Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor

Phase 1 Completed 38 enrolled Seoul National University Hospital Green Cross Corporation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a four arm, parallel study. Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).

Timeline

Start: 2008-09
Primary completion: 2009-01
Completion: 2009-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GCPGC	Unknown	30 ug/kg	Subcutaneous
Subject	GCPGC	Unknown	100 ug/kg	Subcutaneous
Subject	GCPGC	Unknown	300 ug/kg	Subcutaneous
Subject	Pegfilgrastim	Protein / enzyme biologic	100 ug/kg	Subcutaneous

Indications

No indication recorded.