A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A (VOYAGER2)

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Haemophilia A

Treatments: Drug: NNC0442-0344 A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07220564

2025-520490-38 (EudraCT Number)

NN7442-8454

U1111-1317-4366 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A

Cohort 2

Experimental group

Description:

Participants will receive oral dose of NNC0442-0344 A.

Treatment:

Drug: NNC0442-0344 A