Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467435
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-14
Brief Title:
Evaluation of K9 in Subjects With Thyroid Eye Disease TED
Sponsor:
Peter Timoney
Organization:
University of Kentucky
Study Overview
Official Title:
Evaluation of K9 in Subjects With Thyroid Eye Disease TED
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects Cohort 1 and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease Cohort 2 Participants will receive study medication one time or for up to 4 weeks Participants will have blood drawn andor complete eye exams and questionnaires
The planned duration of this study is 6 weeks
The planned duration of this study is 6 weeks
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