Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721989
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2023-02-01
Brief Title:
A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Comparative Bioavailability Study of a Single Dose of Ziltivekimab Formulation B in a Manual Syringe Formulation D in a Manual Syringe and Formulation C in a Pen-injector
Status:
COMPLETED
Status Verified Date:
2024-01
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:
A research study to investigate how quickly and to what extent different compositions of the study medicine ziltivekimab are absorbed transported and eliminated from the body Ziltivekimab is not yet approved for market The study medicine will be injected under the skin this is called subcutaneous administration Two different administration methods will be compared a syringe and a pen-injector A pen-injector is a device that is developed to make injections more easy and convenient They are for example used by diabetes patients to inject insulin It will also be investigated how safe ziltivekimab is and how well it is tolerated when it is used by healthy participants Ziltivekimab has already been administered to patients with chronic kidney disease or rheumatoid arthritis The current study will be the first study where ziltivekimab will be given to healthy participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1277-3676 | OTHER | World Health Organization WHO | None |
| 2022-001862-37 | EUDRACT_NUMBER | None | None |