Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681845
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-01-04
Brief Title:
A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Study to Demonstrate Bioequivalence of a Single Subcutaneous Administration of NNC0365-3769 Mim8 With the DV3407-C1 Pen Injector Versus a Syringe and Enhanced Cartridge in Healthy Male Participants
Status:
COMPLETED
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:
Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A The study aims to show similar levels of Mim8 in blood when using a new pen injector called DV3407-C1 pen injector and when using a syringe and cartridge The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A The participants will get Mim8 as injection under the skin subcutaneously of the belly using the DV3407-C1 pen injector and a needle hereinafter referred to as pen injector or using a needle and syringe from a cartridge hereafter called syringe and cartridge The participants will receive one injection with Mim8 either with the DV3407-C1 pen injector or with a syringe and cartridge The study participation will last up to 20 weeks Only healthy men can take part in the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1277-9765 | OTHER | None | None |
| 2022-002318-18 | EUDRACT_NUMBER | World Health Organization WHO | None |