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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiration Disorders Respiratory Tract Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Jewish Medical and Research Center, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FG-3019

Drug

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

Other names: Recombinant human monoclonal antibody

Primary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: Baseline up to 12 months
Area Under the Plasma Concentration Vs Time Curve (AUC) of FG-3019

Time frame: Through 30 hours postdose
Number of Participants With Human Anti-human Antibody (HAHA)

Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2004
First posted: Dec 22, 2003
Registry last updated: Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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