Completed

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

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What is being tested

FG-3019

Drug
Who is being recruted

Fibrosis+4

+ Lung Diseases

+ Pathologic Processes

From 21 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorFibroGen
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 8, 2003

Actual date on which the first participant was enrolled.

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 TitleA Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis 
NCT00074698
Principal SponsorFibroGen
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibrosisLung DiseasesPathologic ProcessesPulmonary FibrosisRespiratory Tract DiseasesLung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

National Jewish Medical and Research Center

Denver, United StatesSee the location
Suspended

University of Michigan Health Sciences

Ann Arbor, United States
Suspended

Southwestern Medical School

Dallas, United States
Suspended

University of Washington Medical Center

Seattle, United States
Completed4 Study Centers