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

NCT07220564 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN7442-8454U1111-1317-43662025-520490-38
• Study Type: interventional
• Target: 30
• Locations: 12 countries
• Sites: 33

Brief 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.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events

  Measured as count of events.

  From time of dosing (Day 1) to end of follow-up (Day 46)

Secondary Outcomes (10)

• Change in D-dimer

  From time of dosing (Day 1) to end of follow-up (Day 46)

• Change in prothrombin fragment 1 and 2

  From time of dosing (Day 1) to end of follow-up (Day 46)

• Change in fibrinogen

  From time of dosing (Day 1) to end of follow-up (Day 46)

• Change in platelets

  From time of dosing (Day 1) to end of follow-up (Day 46)

• Occurrence of anti-Inno8 antibodies

  From time of dosing (Day 1) to end of follow-up (Day 46)

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Cohort 2

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Cohort 3

EXPERIMENTAL

Participants will receive oral dose of NNC0442-0344 A.

Drug: NNC0442-0344 A

Interventions

NNC0442-0344 A DRUG

NNC0442-0344 A will be administered orally.

Also known as: Inno8

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (33)

UC Denver Hemoph & Thrombo Ctr

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Indiana Hemophilia-Thromb Ctr

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Iowa_Iowa City

Iowa City, Iowa, 52242, United States

RECRUITING

Penn State MS Hershey Med Ctr

Hershey, Pennsylvania, 17033-2360, United States

RECRUITING

St Christopher Hosp for Child

Philadelphia, Pennsylvania, 19134, United States

NOT YET RECRUITING

Universitätsklinik für Innere Medizin V

Innsbruck, 6020, Austria

RECRUITING

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

Vienna, 1090, Austria

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique

Bron, 69500, France

NOT YET RECRUITING

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

RECRUITING

Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

Bonn, 53127, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie

Hanover, 30625, Germany

RECRUITING

AOU Careggi Firenze

Florence, 50134, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II di Napoli

Naples, 80131, Italy

RECRUITING

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

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

Katowice, 40-032, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

Lublin, 20-081, Poland

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 60-569, Poland

NOT YET RECRUITING

Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland

RECRUITING

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

Porto, 4050-342, Portugal

NOT YET RECRUITING

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

Porto, 4200-319, Portugal

NOT YET RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital La Fe - Hemostasia y Trombosis

Valencia, 46026, Spain

NOT YET RECRUITING

Skåne US - Koagulationsmottagning

Malmo, 214 28, Sweden

NOT YET RECRUITING

KS Solna - Koagulationsmottagningen

Solna, 171 64, Sweden

NOT YET RECRUITING

Zentrum für Labormedizin

Sankt Gallen, 9008, Switzerland

NOT YET RECRUITING

Queen Elizabeth Hospital, Birmingham - Haemophilia

Birmingham, B15 2TH, United Kingdom

NOT YET RECRUITING

Royal Free Hospital - Haemophilia

London, NW3 2QG, United Kingdom

RECRUITING

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5); IT (2); GB (3); DE (3); ES (5); AU (2); PL (6); SE (2); CH (1); FR (1); BE (1); PT (2)