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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: FG-3019

• Registration Number: NCT00074698
• Lead Sponsor: FibroGen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-08
• Study First Submitted: 2003-12-18
• Study First Submitted QC: 2003-12-19
• Study First Posted: 2003-12-22
• Study Completion: 2004-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FG-3019 Medium Dose	FG-3019	Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.
FG-3019 Low Dose	FG-3019	Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.
FG-3019 High Dose	FG-3019	Participants will receive a single IV infusion of FG-3019 high dose on Day 0.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

University of Michigan Health Sciences; 🇺🇸 Ann Arbor, Michigan, United States

Southwestern Medical School; 🇺🇸 Dallas, Texas, United States

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States