Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438263
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-label Phase 1 Single Dose Randomized Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab AMG 451 Autoinjector and Vial in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-10
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 main objective of this study is to evaluate the pharmacokinetics PK of rocatinlimab given as a single subcutaneous SC autoinjector dose compared to vial in healthy participants
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