drugset / Trial / NCT00125385

Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT00125385 ↗

Phase 1 Completed 25 enrolled Genzyme, a Sanofi Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.

Timeline

Start
2005-07
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fresolimumab Protein / enzyme biologic 0.3 mg/kg Intravenous
Subject Fresolimumab Protein / enzyme biologic 1 mg/kg Intravenous
Subject Fresolimumab Protein / enzyme biologic 2 mg/kg Intravenous
Subject Fresolimumab Protein / enzyme biologic 4 mg/kg Intravenous
Subject Fresolimumab Protein / enzyme biologic 8 mg/kg Intravenous