Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074698
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2003-12-18
Brief Title:
Safety and Tolerability Study of FG-3019 in Participants With Idiopathic Pulmonary Fibrosis
Sponsor:
FibroGen
Organization:
FibroGen
Study Overview
Official Title:
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
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None