Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331624
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-02-01
Brief Title:
Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF
Sponsor:
GRI Bio Operations Inc
Organization:
GRI Bio Operations Inc
Study Overview
Official Title:
Biomarker Modulation and the Inhibition of Natural Killer Type 1 NKT1 Cells by Oral GRI-0621 in Patients With Idiopathic Pulmonary Fibrosis IPF
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase 2a randomized double-blind multi-center placebo-controlled parallel-design 2-arm study Approximately 36 subjects with IPF will be randomized in a 21 ratio for GRI-0621 45mg or Placebo GRI-0621 dose of 45mg will be compared with placebo following once daily oral administration for 12 weeks Concurrently a Sub-Study will be conducted examining the number and activity of NKT cells in BAL for up to 12 eligible subjects across various centers An interim analysis will be performed when 24 subjects complete 6 weeks of treatment approximately 8 placebo subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None