A Research Study Investigating Mim8 in People With Haemophilia A
Status:
Recruiting
Trial end date:
2024-01-29
Target enrollment:
Participant gender:
Summary
This study consists of 2 parts. Part 1 looks at the safety and tolerability when the study
medicine Mim8 is given to healthy subjects for the first time. The obtained results will help
to perform a second part of the study with patients who suffer from a bleeding disorder
called haemophilia A. Haemophilia A is an inherited condition caused by a lack of a protein
called factor VIII. Mim8 works in the body for a longer time than most other products used by
patients with haemophilia A. Mim8 is designed for once weekly or once monthly administration.
In Part 1, participants will be injected only once with either Mim8 or a "dummy" medicine
(placebo) under the tummy skin - which one will be decided by chance. In this study, Mim8
will be used for the first time in humans. Mim8 is a new medicine and cannot be prescribed by
doctors in any country. Mim8 belongs to a group of medicines called antibodies. Mim8 is
designed to take over the function of the missing factor VIII in haemophilia A patients. Part
1 of the study will last for up to 20 weeks. Participants will attend a screening visit,
followed by a 12-day in-house visit where they will have to stay in the study unit. This is
followed by 10 ambulatory visits with the study doctor throughout the remaining part of the
study. Assessments will include several blood tests and electrocardiograms (ECGs). In part 2
of the study, people with haemophilia A - with or without inhibitors - will be given
injections with a thin needle in the skin of their stomach, either weekly or monthly. Part 2
of the study will last for 120 weeks.