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NCT Number: NCT07220564

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Universitätsklinik für Innere Medizin V, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0442-0344 A

Drug

NNC0442-0344 A will be administered orally.

Other names: Inno8

Primary outcomes

  1. Number of treatment emergent adverse events

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

    Measured as count of events.

Secondary outcomes

  1. Change in D-dimer

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

    Measured as absolute and percentage (%).

  2. Change in prothrombin fragment 1 and 2

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

    Measured as absolute and %.

  3. Change in fibrinogen

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

    Measured as absolute and %.

  4. Change in platelets

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

    Measured as absolute and %.

  5. Occurrence of anti-Inno8 antibodies

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

    Measured as count.

  6. Cmax: the maximum concentration of Inno8 after multiple doses

    Time frame: From Day 10 to Day 11

    Measured as nanograms per millilitre (ng/mL).

  7. Tmax: the time to Cmax after last multiple dose

    Time frame: From day 10 to Day 11

    Measured as hours.

  8. Tmax: the time to Cmax after first dose

    Time frame: From Day 1 to Day 2

    Measured as hours.

  9. AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses

    Time frame: From Day 10 to Day 11

    Measured as nanograms*day per millilitre (ng*day/mL).

  10. Maximum thrombin generation (peak height)

    Time frame: From Day 10 to Day 11

    Measured as nanomolar (nM).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A

Acronym: VOYAGER2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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