NCT07220564RecruitingPhase 1
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- 23 Oct 2025
- Primary completion date
- 5 Feb 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT07220564
- EU CT number
- 2025-520490-38-00
- EudraCT number
- 2025-520490-38
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 23 Oct 2025 to the primary completion date, 5 Feb 2027
- 33 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
- Ongoing or planned immune tolerance induction therapy.
Other illness
- 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 known coagulation disorders other than haemophilia A.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Other
- Body mass index ≥30.0 kilogram per square meter (kg/m\^2).
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers
Sites (33)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Not yet recruiting |
| Zentrum für Labormedizin Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Completed |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Queen Elizabeth Hospital, Birmingham - Haemophilia Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| Royal Free Hospital - Haemophilia Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Active, not recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Active, not recruiting |
| UC Denver Hemoph & Thrombo Ctr Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Penn State MS Hershey Med Ctr Coordinator of this site? Confirm its status | Hershey | United States | Recruiting |
| Indiana Hemophilia-Thromb Ctr Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University Of Iowa_Iowa City Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| St Christopher Hosp for Child Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.