A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- FibroGen
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
FG-3019 High Dose
Participants will receive a single IV infusion of FG-3019 high dose on Day 0.
Intervention: FG-3019 (Drug)
FG-3019 Low Dose
Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0.
Intervention: FG-3019 (Drug)
FG-3019 Medium Dose
Participants will receive a single IV infusion of FG-3019 medium dose on Day 0.
Intervention: FG-3019 (Drug)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported