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Research Study for Inno8 in Haemophilia A

This study is looking at how different doses of the medicine NNC0442-0344 A (also called Inno8) work in the bodies of men with haemophilia A. Haemophilia A is a genetic bleeding disorder where your blood doesn't clot properly. The main goal is to see if NNC0442-0344 A is safe for people with haemophilia A by tracking any side effects. To join, you must be a man between 18 and 64 years old, weigh at least 45 kilograms, and have a diagnosis of congenital haemophilia A with a factor VIII (FVIII) activity of 15% or less. This study plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive the study medicine. It aims to enroll 30 participants.
What's involved
The study will last for about 11 weeks. NNC0442-0344 A will be given orally.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the time of dosing on Day 1 until the end of follow-up on Day 46.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220564

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

Recruiting
PHASE1Ages 18–64InterventionalTreatment
Novo Nordisk A/S
~30 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:NNC0442-0344 A

At a glance

Recruiting sites
26 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment emergent adverse events
Measured over From time of dosing (Day 1) to end of follow-up (Day 46)

Conditions

Haemophilia A

Explore related trials

Hemophilia AF8 wt Allele

Where it's being run

33 sites across 15 states
Poland6
Spain5
Germany3
United Kingdom3
Pennsylvania2
Austria2
Italy2
Portugal2

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of treatment emergent adverse eventsFrom time of dosing (Day 1) to end of follow-up (Day 46)

    Measured as count of events.