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NCT07220564PHASE1RecruitingAccepts Healthy Volunteers

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

Novo Nordisk A/S

Start Date

10/23/2025

Completion Date

2/5/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 64 years

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

DRUG

NNC0442-0344 A

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Conditions

Haemophilia A

Locations

UC Denver Hemoph & Thrombo Ctr

Aurora, Colorado 80045

United States

Indiana Hemophilia-Thromb Ctr

Indianapolis, Indiana 46260

United States

University of Iowa_Iowa City

Iowa City, Iowa 52242

United States

Penn State MS Hershey Med Ctr

Hershey, Pennsylvania 17033-2360

United States

St Christopher Hosp for Child

Philadelphia, Pennsylvania 19134

United States

Universitätsklinik für Innere Medizin V

Innsbruck, 6020

Austria

AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

Vienna, 1090

Austria

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique

Bron, 69500

France

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

Berlin, 10249

Germany

Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

Bonn, 53127

Germany

Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie

Hanover, 30625

Germany

AOU Careggi Firenze

Florence, 50134

Italy

Azienda Ospedaliera Universitaria Federico II di Napoli

Naples, 80131

Italy

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, 40-032

Poland

Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

Lublin, 20-081

Poland

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 60-569

Poland

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776

Poland

ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia

Porto, 4050-342

Portugal

ULS São João, E.P.E._H.São João_Imunohemoterapia

Porto, 4200-319

Portugal

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Regional Universitario de Málaga

Málaga, 29010

Spain

Hospital Clinico Universitario de Salamanca

Salamanca, 37007

Spain

Hospital La Fe - Hemostasia y Trombosis

Valencia, 46026

Spain

Skåne US - Koagulationsmottagning

Malmö, 214 28

Sweden

KS Solna - Koagulationsmottagningen

Solna, 171 64

Sweden

Zentrum für Labormedizin

Sankt Gallen, 9008

Switzerland

Queen Elizabeth Hospital, Birmingham - Haemophilia

Birmingham, B15 2TH

United Kingdom

Royal Free Hospital - Haemophilia

London, NW3 2QG

United Kingdom

Royal Hallamshire Hospital

Sheffield, S10 2JF

United Kingdom