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A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects 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.
Details
| Lead sponsor | Kyntra Bio |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2003-12-08 |
| Completion | 2004-05 |
Conditions
- Idiopathic Pulmonary Fibrosis
Interventions
- FG-3019
Primary outcomes
- 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
Countries
United States