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

Study Overview
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Brief Summary
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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.

Official Title
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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants

Conditions
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Healthy Volunteers - Haemophilia A

Intervention / Treatment
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* Drug: Mim8 B, 10 mg/mL
* Drug: Mim8 B, 100 mg/mL
* Drug: Mim8 B, placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose level 1<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 10 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 2<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 10 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|
| Experimental: Dose level 3<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 4<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 10 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|
| Experimental: Dose level 5<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 6<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 10 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|
| Experimental: Dose level 7<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|
| Experimental: Dose level 8<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 9<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 10<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|
| Experimental: Dose level 11<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;Drug: Mim8 B, placebo<br>* Placebo will be used to dilute the IMP to different Mim8 concentrations<br>|
| Experimental: Dose level 12<br>All participants will receive a single dose of Mim8 | Drug: Mim8 B, 100 mg/mL<br>* 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.<br>* Other names: NN0365-3769;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events | Count | From time of dosing (day 1) to day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of injection site reactions | Count | From time of dosing (day 1) to day 113 | 
| Cmax, SD: the maximum concentration of Mim8 after a single dose | messured in μg/mL | 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 | 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 | 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 | From time of dosing (day 1) to day 113 | 
| Change in activated partial thromboplastin time | messured in seconds | From baseline (day 1) to day 113 |