This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part 1: Number of treatment emergent adverse events
Timeframe: From time of dosing (Day 1) to Week 16
Part 2: Number of treatment emergent adverse events
Timeframe: From time of first dosing (Day 1) to Week 12
Part 2, extension: Number of treatment emergent adverse events
Timeframe: From Week 12 up to Week 176 (16 weeks after last dose)