A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men

Launched by NOVO NORDISK A/S · Oct 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medicine called Inno8 to see how different doses work in healthy men. The goal is to ensure that Inno8 is safe to use, which is important for its future development for treating people with Haemophilia A, a condition where blood doesn’t clot properly. The study will be done in two parts: in the first part, participants will receive either one injection of Inno8 or a placebo (a dummy medicine with no effect), and in the second part, they will take 1-2 tablets daily for ten days. Participants will be monitored for about 9 to 11 weeks, depending on which part they are in.

To be eligible for this trial, you must be a healthy male aged 18 to 45, with a body weight between 60 and 100 kilograms. You'll also need to meet certain health criteria, meaning you should not have a history of blood clotting issues or other specific health conditions. If you join the study, you’ll help researchers understand how Inno8 works, and you’ll be contributing to important medical research that could benefit future patients with Haemophilia A.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male
• • Age 18-45 years (both inclusive) at the time of signing informed consent
• • Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m\^2) (both inclusive)
• • Body weight between 60.0 and 100.0 Kilogram (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:
• • Factor VIII activity greater than or equal to (≥) 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
• * 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