Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425861
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-15
Brief Title:
A First in Human Trial Evaluating THB335 in Healthy Participants
Sponsor:
Third Harmonic Bio Inc
Organization:
Third Harmonic Bio Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 1 Single and Multiple Ascending Dose Study to Assess the Safety Pharmacokinetics Pharmacodynamics and Food Effect of THB335 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-05
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 study is a double blind randomized placebo-controlled Phase 1 study in two parts single ascending doses and food effect Part 1 and multiple ascending doses Part 2
Detailed Description:
THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells
The study will evaluate the safety pharmacokinetics pharmacodynamics and food effect profile of THB335 administered orally in healthy participants
The study will evaluate the safety pharmacokinetics pharmacodynamics and food effect profile of THB335 administered orally in healthy participants
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