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

NCT00074698 | Completed Phase 1

• 1 other identifier: FGCL-MC3019-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic pulmonary fibrosis; IPF; Pulmonary fibrosis; Respiratory disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

FG-3019 Low Dose

EXPERIMENTAL

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

Drug: FG-3019

FG-3019 Medium Dose

EXPERIMENTAL

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

Drug: FG-3019

FG-3019 High Dose

EXPERIMENTAL

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

Drug: FG-3019

Interventions

FG-3019 DRUG

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

Also known as: Recombinant human monoclonal antibody

FG-3019 High Dose; FG-3019 Low Dose; FG-3019 Medium Dose

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a diagnosis of idiopathic pulmonary fibrosis (IPF) by clinical features and surgical lung biopsy or according to the American Thoracic Society criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (4)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

University of Michigan Health Sciences

Ann Arbor, Michigan, 48109, United States

Location

Southwestern Medical School

Dallas, Texas, 75390, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Respiration Disorders

Interventions

pamrevlumab; Stamulumab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2003
• First Posted: December 22, 2003
• Study Start: December 8, 2003
• Study Completion: May 1, 2004
• Last Updated: July 12, 2023

Record last verified: 2023-07

Locations

US (4)