NCT00125385

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

Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
BIOLOGICAL	GC1008	0.3 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
BIOLOGICAL	GC1008	1.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
BIOLOGICAL	GC1008	2.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
BIOLOGICAL	GC1008	4.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.
BIOLOGICAL	GC1008	8.0 mg/kg, IV on Day 0 and return to the clinic on 3,7, 10, 14, 21, 28, 42, 56, 84, 112, 140 post infusion for safety follow-up.

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-08-01
• Last updated: 2015-04-13

Locations

8 sites across 2 countries: United States, Belgium