A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 we
| Condition(s) | Haemophilia A |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks. |
| Who can participate | Inclusion Criteria: * Male * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body weight greater than or equal to (≥) 45 kilograms (kgs). * Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records. Exclusion Criteria: * Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening. * Body mass index ≥30.0 kilogram per square meter (kg/m\^2). * 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. * A |
| Ages | 18 Years to 64 Years |
| Sex | Male |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Novo Nordisk A/S |
| Locations | Aurora, Colorado, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Hershey, Pennsylvania, United States; Philadelphia, Pennsylvania, United States; Innsbruck, Austria (+27 more sites) |
| Start date | 2025-10-23 |
| NCT ID | NCT07220564 |
| Official listing | https://clinicaltrials.gov/study/NCT07220564 |