RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Male
- Age 18-64 years (both inclusive) at the time of signing the willing to sign a consent form.
- 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.
Who Should NOT Join This Trial:
- 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.
- Any known coagulation disorders other than haemophilia A.
- Ongoing or planned immune tolerance induction therapy.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
* Any known coagulation disorders other than haemophilia A.
* Ongoing or planned immune tolerance induction therapy.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Treatments Being Tested
DRUG
NNC0442-0344 A
NNC0442-0344 A will be administered orally.
Locations (20)
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States
University of Iowa_Iowa City
Iowa City, Iowa, United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
Universitätsklinik für Innere Medizin V
Innsbruck, Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, Germany
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover, Germany
AOU Careggi Firenze
Florence, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Queen Elizabeth Hospital, Birmingham - Haemophilia
Birmingham, United Kingdom