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

Novo Nordisk A/S · NCT07220564

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–64 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
30
US sites recruiting
5
Study start
October 23, 2025
Record last updated
September 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: NNC0442-0344 A

Conditions: Haemophilia A

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com
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