Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease
Eligibility Criteria
Key Inclusion Criteria: have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria Key Exclusion Criteria: have a history of significant exposure to organic or inorganic dust or drugs known to cause pulmonary fibrosis 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) Other inclusion and exclusion criteria may apply.
Sites / Locations
- National Jewish Medical and Research Center
- University of Michigan Health Sciences
- Southwestern Medical School
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
FG-3019 Low Dose
FG-3019 Medium Dose
FG-3019 High Dose
Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.
Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.
Participants will receive a single IV infusion of FG-3019 high dose on Day 0.