Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924140
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2021-06-08
Brief Title:
A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Randomized Open-Label Parallel-Arm Study to Assess the Absolute Bioavailability of a Single Fixed Subcutaneous Dose of Aducanumab BIIB037 Compared to a Single Weight-Based Intravenous Dose in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-04
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 this study is to evaluate the absolute bioavailability of a single fixed subcutaneous SC dose of aducanumab compared with a single weight-based intravenous IV dose of aducanumab in healthy volunteers
The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic PK parameters of a single fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers
The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic PK parameters of a single fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers
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