Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

Sponsor

FibroGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00074698

Collaborator

(none)

Enrollment

Locations

6.8

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of FG-3019, a therapeutic antibody designed to block the pro-fibrotic activity of connective tissue growth factor (CTGF). CTGF triggers the production of collagen and fibronectin, which cause scarring and thickening of the lungs. Approximately 18 to 27 males and females, 21 to 80 years of age with a diagnosis of idiopathic pulmonary fibrosis (IPF) will be enrolled in this study. The duration of the study is approximately one month, during which patients will receive a single infusion of FG-3019. In addition, there will be two follow-up visits 6 and 12 months after receiving the study drug.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: FG-3019	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

are 21 to 80 years of age
have a diagnosis of IPF by surgical lung biopsy or according to the American Thoracic Society criteria

Exclusion Criteria:

have a history of significant exposure to organic or inorganic dust or drugs known to cause IPF
have interstitial lung disease other than IPF
have pulmonary fibrosis associated with connective tissue disease
have other forms of idiopathic interstitial pneumonia, such as desquamative interstitial pneumonia, acute interstitial pneumonia, nonspecific interstitial pneumonia, or cryptogenic organizing pneumonia
have end-stage IPF (total lung capacity of less than 45% of predicted value)
are listed for lung transplantation at the time of study enrollment
have significant heart problems
are pregnant or lactating (if female)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Jewish Medical and Research Center	Denver	Colorado	United States	80206
2	University of Michigan Health Sciences	Ann Arbor	Michigan	United States	48109
3	Southwestern Medical School	Dallas	Texas	United States	75390
4	University of Washington Medical Center	Seattle	Washington	United States	98195