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

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity 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. Participants will be assigned sequentially to one of the 3 dose group: Low, medium, and high FG-3019.

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

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: FG-3019


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FG-3019 Low Dose<br>Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. | Drug: FG-3019<br>* FG-3019 will be administered per dose and schedule specified in the arm description.<br>* Other names: Recombinant human monoclonal antibody;|
| Experimental: FG-3019 Medium Dose<br>Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. | Drug: FG-3019<br>* FG-3019 will be administered per dose and schedule specified in the arm description.<br>* Other names: Recombinant human monoclonal antibody;|
| Experimental: FG-3019 High Dose<br>Participants will receive a single IV infusion of FG-3019 high dose on Day 0. | Drug: FG-3019<br>* FG-3019 will be administered per dose and schedule specified in the arm description.<br>* Other names: Recombinant human monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) |  | Baseline up to 12 months | 
| Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019 |  | Through 30 hours postdose | 
| Number of Participants With Human Anti-human Antibody (HAHA) |  | Baseline up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease