Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563856
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Single Ascending Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of TEPEZZA Subcutaneous Administration in Healthy Adult Subjects
Status:
COMPLETED
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 primary objective of this study is to assess the pharmacokinetics PK parameters of a single subcutaneous SubQ infusion of TEPEZZA with and without ENHANZE Drug Product EDP at 2 dose levels in healthy adult participants
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