Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206811
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-12-20
Brief Title:
Phase 1 Study to Investigate OD-07656 in Healthy Adult Participants
Sponsor:
Odyssey Therapeutics
Organization:
Odyssey Therapeutics
Study Overview
Official Title:
A Four-part Phase 1 Double-blind Study to Investigate the Safety Tolerability Pharmacokinetics PK and Pharmacodynamics PD With Single and Multiple Ascending Oral Doses of OD-07656 in Healthy Adult Male and Female Participants
Status:
RECRUITING
Status Verified Date:
2024-02
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:
First-in-human study to provide an assessment of the safety tolerability pharmacokinetics PK including food effects and a drug-drug interaction and pharmacodynamics PD of OD-07656 after administration of ascending single and multiple oral doses to healthy male and female participants in view of treating inflammatory bowel disease IBD including Crohns disease and ulcerative colitis Blau syndrome and spondyloarthritis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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