RECRUITING Phase 1 ClinicalTrials.gov

A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A

Sponsor: Novo Nordisk A/S • ClinicalTrials.gov ID: NCT07220564

Registry updated: 2026-09-18

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Description

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.

Interventions

NNC0442-0344 A (Drug)
NNC0442-0344 A will be administered orally.

Eligibility criteria

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.

Conditions

Haemophilia A

Locations

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
Cliniques universitaires Saint-Luc — Brussels, Belgium
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique — Bron, France
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
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach — Katowice, Poland
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku — Lublin, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan, Poland
Instytut Hematologii i Transfuzjologii — Warsaw, Poland
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia — Porto, Portugal
ULS São João, E.P.E._H.São João_Imunohemoterapia — Porto, Portugal
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
Hospital La Fe_Hemostasia y Trombosis — Valencia, Spain
Skåne US - Koagulationsmottagning — Malmö, Sweden
KS Solna - Koagulationsmottagningen — Solna, Sweden
Zentrum für Labormedizin — Sankt Gallen, Switzerland
Queen Elizabeth Hospital, Birmingham - Haemophilia — Birmingham, United Kingdom
Royal Free Hospital - Haemophilia — London, United Kingdom
Royal Hallamshire Hospital — Sheffield, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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