Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262477
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-08
Brief Title:
A Study to Evaluate the Pharmacokinetics Safety and Immunogenicity of BIIB800 Subcutaneously SC Compared to Actemra in Healthy Male Participants
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Phase I Study to Evaluate the Pharmacokinetics Safety and Immunogenicity of BIIB800 sc Compared to Actemra in Healthy Male 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:
The primary objective of the study is to show equivalence in pharmacokinetics PK of BIIB800 and Actemra following SC administration of a single dose to healthy male participants The secondary objective of the study is to evaluate PK over time clinical safety pharmacodynamic PD profiles and immunogenicity of BIIB800 and Actemra
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