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Recruiting Phase 1 NCT07220564

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

Phase 1 – testing safety in a small group of people
Conditions: Haemophilia A

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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. * 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.
Interventions
NNC0442-0344 A
DRUG
Locations 33
Austria (2)
Universitätsklinik für Innere Medizin V
Innsbruck
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna
Belgium (1)
Cliniques universitaires Saint-Luc
Brussels
NOT_YET_RECRUITING
France (1)
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
Bron
NOT_YET_RECRUITING
Germany (3)
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn
NOT_YET_RECRUITING
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover
Italy (2)
AOU Careggi Firenze
Florence
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples
Poland (6)
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
Uniwersyteckie Centrum Kliniczne
Gdansk
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice
NOT_YET_RECRUITING
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
Lublin
NOT_YET_RECRUITING
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan
NOT_YET_RECRUITING
Instytut Hematologii i Transfuzjologii
Warsaw
Portugal (2)
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia
Porto
NOT_YET_RECRUITING
ULS São João, E.P.E._H.São João_Imunohemoterapia
Porto
NOT_YET_RECRUITING
Spain (5)
Hospital Vall d'Hebron
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario de Málaga
Málaga
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital La Fe - Hemostasia y Trombosis
Valencia
NOT_YET_RECRUITING
Sweden (2)
Skåne US - Koagulationsmottagning
Malmo
NOT_YET_RECRUITING
KS Solna - Koagulationsmottagningen
Solna
NOT_YET_RECRUITING
Switzerland (1)
Zentrum für Labormedizin
Sankt Gallen
NOT_YET_RECRUITING
United Kingdom (3)
Queen Elizabeth Hospital, Birmingham - Haemophilia
Birmingham
NOT_YET_RECRUITING
Royal Free Hospital - Haemophilia
London
Royal Hallamshire Hospital
Sheffield
NOT_YET_RECRUITING
United States (5)
UC Denver Hemoph & Thrombo Ctr
Aurora , Colorado
NOT_YET_RECRUITING
Penn State MS Hershey Med Ctr
Hershey , Pennsylvania
Indiana Hemophilia-Thromb Ctr
Indianapolis , Indiana
University of Iowa_Iowa City
Iowa City , Iowa
St Christopher Hosp for Child
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
23.10.2025
Completion date
05.02.2027
Registry ID
NCT07220564
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.