Last updated on March 2020

A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People and Patients With Bleeding Disorder

Brief description of study

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 28 or 31 weeks. This depends on whether the study medicine is given weekly or monthly. Participants will have either 19 or 22 visits with the doctor. The number of visits depends on whether the study medicine is given weekly or monthly. Participants will hear more about which other medicines they can use while they are in the study. Participants will fill in a diary between visits.

Clinical Study Identifier: NCT04204408

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