Trials / Completed
CompletedNCT00074698
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Kyntra Bio · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FG-3019 | FG-3019 will be administered per dose and schedule specified in the arm description. |
Timeline
- Start date
- 2003-12-08
- Completion
- 2004-05-01
- First posted
- 2003-12-22
- Last updated
- 2023-07-12
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00074698. Inclusion in this directory is not an endorsement.