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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FG-3019 Low Dose | Experimental | Participants will receive a single intravenous (IV) infusion of FG-3019 low dose on Day 0. |
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| FG-3019 Medium Dose | Experimental | Participants will receive a single IV infusion of FG-3019 medium dose on Day 0. |
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| FG-3019 High Dose | Experimental | Participants will receive a single IV infusion of FG-3019 high dose on Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FG-3019 | Drug | FG-3019 will be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States | ||
| University of Michigan Health Sciences |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D011658 | Pulmonary Fibrosis |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C560078 | pamrevlumab |
| C506829 | Stamulumab |
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|
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Southwestern Medical School | Dallas | Texas | 75390 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |