Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
12–any
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Single ascending dose part 1:
Male, aged 18-45 years (both inclusive) at the time of signing informed consent
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
Multiple ascending dose part 2:
Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical records
Exploratory biomarker cohort:
Male, aged equal to or above 12 years at the time of signing informed consent (Germany and Japan have local requirements)
Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical recordsv
You may not be if
Part 1:
Factor VIII activity equal to or above 150% at screening
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
Part 2:
Known congenital or acquired coagulation disorders other than haemophilia A
Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
Any autoimmune disease that may increase the risk of thrombosis
Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
Ongoing or planned immune tolerance induction therapy
Exploratory biomarker cohort:
Known congenital or acquired coagulation disorders other than haemophilia A
Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
Any autoimmune disease that may increase the risk of thrombosis
Ongoing or planned immune tolerance induction therapy
Clareo Health | A Research Study Investigating Mim8 in People With Haemophilia A
