Healthy Volunteers - Haemophilia A
Conditions
Brief summary
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.
Interventions
DRUGMim8 B, 10 mg/mL
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.
DRUGMim8 B, 100 mg/mL
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.
DRUGMim8 B, placebo
Placebo will be used to dilute the IMP to different Mim8 concentrations
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index between 18.5 and 29.9 kg/m\^2 (both inclusive) * Body weight between 60.0 to 100.0 kg (both inclusive) * 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.
Exclusion criteria
* 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 * Factor VIII activity greater than or equal to150% at screening * Any of the thrombophilia markers listed below: * Protein C, protein S or antithrombin below the lower normal laboratory range * Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events | From time of dosing (day 1) to day 113 | Count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax, SD: the maximum concentration of Mim8 after a single dose | From time of dosing (day 1) to day 113 | messured in μg/mL |
| AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose | From time of dosing (day 1) to day 113 | messured in μg\*day/mL |
| Number of injection site reactions | From time of dosing (day 1) to day 113 | Count |
| tmax, SD: the time to maximum concentration of Mim8 after a single dose | From time of dosing (day 1) to day 113 | messured in days |
| Change in activated partial thromboplastin time | From baseline (day 1) to day 113 | messured in seconds |
| t1/2, SD: the terminal half-life of Mim8 after a single dose | From time of dosing (day 1) to day 113 | messured in days |
Countries
Germany
Outcome results
None listed