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

Not Applicable

Not yet recruiting

• Conditions: Haemophilia A
• Interventions: Drug: NNC0442-0344 A

• Registration Number: NCT07220564
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-22
• Last Update Submitted: 2025-10-22
• Study Start: 2025-10-23
• Study First Posted: 2025-10-24
• Last Update Posted: 2025-10-24
• Primary Completion: 2026-05-26
• Study Completion: 2026-05-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	NNC0442-0344 A	Participants will receive oral dose of NNC0442-0344 A.
Cohort 2	NNC0442-0344 A	Participants will receive oral dose of NNC0442-0344 A.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as count of events.

Secondary Outcome Measures

Name	Time	Method
Change in D-dimer	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as absolute and percentage (%).
Change in prothrombin fragment 1 and 2	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as absolute and %.
Change in fibrinogen	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as absolute and %.
Change in platelets	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as absolute and %.
Occurrence of anti-Inno8 antibodies	From time of dosing (Day 1) to end of follow-up (Day 46)	Measured as count.
Cmax: the maximum concentration of Inno8 after multiple doses	From Day 10 to Day 11	Measured as nanograms per millilitre (ng/mL).
Tmax: the time to Cmax after last multiple dose	From day 10 to Day 11	Measured as hours.
Tmax: the time to Cmax after first dose	From Day 1 to Day 2	Measured as hours.
AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses	From Day 10 to Day 11	Measured as nanograms\*day per millilitre (ng\*day/mL).
Maximum thrombin generation (peak height)	From Day 10 to Day 11	Measured as nanomolar (nM).

Trial Locations

Locations (18)

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

Universitätsklinik für Innere Medizin V; 🇦🇹 Innsbruck, Austria

AKH - Klin. Abt. f. Haematologie u. Haemostaseologie; 🇦🇹 Vienna, Austria

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain; 🇩🇪 Berlin, Germany

Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie; 🇩🇪 Hanover, Germany

AOU Careggi Firenze; 🇮🇹 Florence, Italy

Azienda Ospedaliera Universitaria Federico II di Napoli; 🇮🇹 Napoli, Italy

Uniwersytecki Szpital Kliniczny w Bialymstoku; 🇵🇱 Bialystok, Poland

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