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

Last updated: December 29, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

1

Condition

Hemophilia

Treatment

NNC0442-0344 A

Clinical Study ID

NCT07220564
NN7442-8454
U1111-1317-4366
2025-520490-38
  • Ages 18-64
  • Male
  • Accepts Healthy Volunteers

Study 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

Inclusion

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 orequal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medicalrecords.

Exclusion

Exclusion Criteria:

  • Current or prior exposure to any prophylactic treatment for haemophilia A within 5half-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-degreerelative(s) with unprovoked deep vein thrombosis.

  • Any clinical signs or established diagnosis of venous or arterial thromboembolicdisease.

  • Any known coagulation disorders other than haemophilia A.

  • Ongoing or planned immune tolerance induction therapy.

  • Presence of clinically significant gastrointestinal disorders potentially affectingabsorption of drugs and/or nutrients, as judged by the investigator.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: NNC0442-0344 A
Phase: 1
Study Start date:
October 23, 2025
Estimated Completion Date:
December 21, 2026

Connect with a study center

  • Universitätsklinik für Innere Medizin V

    Innsbruck 2775220, 6020
    Austria

    Active - Recruiting

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

    Vienna 2761369, 1090
    Austria

    Active - Recruiting

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin 2950159, 10249
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • AOU Careggi Firenze

    Florence 3176959, 50134
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II di Napoli

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok 776069, 15-276
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk 3099434, 80-214
    Poland

    Active - Recruiting

  • Instytut Hematologii i Transfuzjologii

    Warsaw 756135, 02-776
    Poland

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga 2514256, 29010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca 3111108, 37007
    Spain

    Active - Recruiting

  • West Midlands Adult Comprehensive Care Haemophilia

    Birmingham 2655603, B15 2TH
    United Kingdom

    Site Not Available

  • Royal Free Haemophilia Comprehensive Care Centre

    London 2643743, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital - Haemophilia

    London 2643743, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Indiana Hemophilia-Thromb Ctr

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Active - Recruiting

  • University of Iowa_Iowa City

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Penn State MS Hershey Med Ctr

    Hershey 5193342, Pennsylvania 6254927 17033-2360
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.