About this trial
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male
Age 18-64 years (both inclusive) at the time of signing the informed consent.
Body weight greater than or equal to (≥) 45 kilograms (kgs).
Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.
Disqualifiers
Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
Body mass index ≥30.0 kilogram per square meter (kg/m²).
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.
Trial design
Single group
Treatments tested in this trial
NNC0442-0344 A
DrugNNC0442-0344 A will be administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Number of treatment emergent adverse events
Measured as count of events.
Secondary outcomes
Change in D-dimer
Measured as absolute and percentage (%).
Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Change in fibrinogen
Measured as absolute and %.
Change in platelets
Measured as absolute and %.
Sponsors and contacts
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