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
Haemophilia A
About this trial
This is an interventional treatment trial for Haemophilia A
Eligibility Criteria
Inclusion Criteria: Male aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5 and 29.9 kilogram per square metre (kg/m^2) (both inclusive) at screening. Body weight between 60.0 and 100.0 kg (both inclusive) at screening. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: Increased risk of thrombosis, e.g., known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis. Any clinical signs or established diagnosis of venous or arterial thromboembolic disease. Factor VIII activity greater than or equal to (≥) 150 percent (%) at screening. Thrombophilia as identified by any of the below laboratory markers at screening: Protein C, protein S or antithrombin less than (<) lower limit of normal (LLN) Factor II activity or activated protein C resistance >upper limit of normal (ULN).
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm 1 (Pilot part)
Arm 2 (Pilot part)
Arm 3 (Bioequivalence part)
Arm 4 (Bioequivalence part)
Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector.
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.