Testing different doses of Inno8 in healthy men
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Oral Doses of Inno8 in Healthy Male Participants
This study tests different doses of a new medicine called Inno8 in healthy men to see how safe it is for future treatment of Haemophilia A.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT06649630 on ClinicalTrials.gov |
What this trial studies
This study evaluates how various doses of the investigational medicine Inno8 affect healthy male participants. It aims to establish the safety profile of Inno8, which is crucial for its future development in treating Haemophilia A. The study consists of two parts: a single ascending dose (SAD) phase where participants receive either Inno8 or a placebo, and a multiple ascending dose (MAD) phase where participants take daily doses of Inno8 or placebo for 10 days. Participants are randomly assigned to receive either the active medication or a dummy treatment.
Who should consider this trial
Good fit: Ideal candidates are healthy males aged 18-45 with a specific body mass index and weight range.
Not a fit: Patients with a history of thrombosis or elevated Factor VIII activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safe and effective treatment for patients with Haemophilia A.
How similar studies have performed: Other studies have shown success with similar dose-escalation approaches in developing new medications.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 1 other locations
- Charité Research Organisation GmbH — Berlin, Germany (Recruiting)
- Charité Research Organisation GmbH — Berlin, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.