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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
FG-3019 will be administered per dose and schedule specified in the arm description.
National Jewish Medical and Research Center
Denver, Colorado, United States
University of Michigan Health Sciences
Ann Arbor, Michigan, United States
Southwestern Medical School
Dallas, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
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
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