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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00074698

Enrollment

Registered

2003-12-22

Start date

2003-12-08

Completion date

2004-05-31

Last updated

2023-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis, IPF, Pulmonary fibrosis, Respiratory disease

Brief summary

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.

Interventions

DRUGFG-3019

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026