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

• Status: Not yet recruiting
• Trial end date: 2022-04-11
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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