NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly). This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body. Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle. The study will last for about 17 - 21 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.
All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.
Placebo will be used to dilute the IMP to different Mim8 concentrations
Novo Nordisk Investigational Site
Mainz, Germany
Novo Nordisk Investigational Site
Neuss, Germany
Number of treatment-emergent adverse events
Count
Time frame: From time of dosing (day 1) to day 113
Number of injection site reactions
Count
Time frame: From time of dosing (day 1) to day 113
Cmax, SD: the maximum concentration of Mim8 after a single dose
messured in μg/mL
Time frame: From time of dosing (day 1) to day 113
AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose
messured in μg\*day/mL
Time frame: From time of dosing (day 1) to day 113
t1/2, SD: the terminal half-life of Mim8 after a single dose
messured in days
Time frame: From time of dosing (day 1) to day 113
tmax, SD: the time to maximum concentration of Mim8 after a single dose
messured in days
Time frame: From time of dosing (day 1) to day 113
Change in activated partial thromboplastin time
messured in seconds
Time frame: From baseline (day 1) to day 113
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