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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-08

Study Completion Date

2004-05-31

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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FG-3019 Low Dose

Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.

Group Type EXPERIMENTAL

FG-3019

Intervention Type DRUG

FG-3019 will be administered per dose and schedule specified in the arm description.

FG-3019 Medium Dose

Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.

Group Type EXPERIMENTAL

FG-3019

Intervention Type DRUG

FG-3019 will be administered per dose and schedule specified in the arm description.

FG-3019 High Dose

Participants will receive a single IV infusion of FG-3019 high dose on Day 0.

Group Type EXPERIMENTAL

FG-3019

Intervention Type DRUG

FG-3019 will be administered per dose and schedule specified in the arm description.

Interventions

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FG-3019

FG-3019 will be administered per dose and schedule specified in the arm description.

Intervention Type DRUG

Other Intervention Names

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Recombinant human monoclonal antibody

Eligibility Criteria

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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

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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No