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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074698
• Other study ID #: FGCL-MC3019-002
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2003
• Est. completion date: May 2004

Study information

• Verified date: July 2023
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

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