Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-06
Brief Title:
A Study to Determine the Biodistribution Safety and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase 1 Open-Label Study to Determine the Biodistribution Safety and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
In this study researchers will learn more about a study drug called BIIB080 BIIB080 is currently a drug under investigation for treatment of Alzheimers disease The main question researchers are trying to answer in this study is how radiolabeled BIIB080 distributes in the brain and spinal cord To help answer this question researchers will use positron emission tomography PET scanner that can detect radiolabeled BIIB080 after a single injection of a small dose of radiolabeled BIIB080 89ZrZr-DFO-BIIB080 and a dose of BIIB080 together via an intrathecal IT injection in healthy volunteers Researchers will also learn about the safety of injecting radiolabeled BIIB080 and BIIB080 together
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