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Looking for participantsPhase1

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

Sponsor: Novo Nordisk A/S

NCT ID: NCT07220564

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
NNC0442-0344 A (drug)
How long the study runs
Study runs about 16 months (dates as stated)
About the drug or intervention
NNC0442-0344 A — drug: NNC0442-0344 A will be administered orally.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 64 Years
Who
Male
Number of participants
30
Started
2025-10-23
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for haemophilia a
  • • Phase1 - 30 participants
  • • This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A

Who can take part?

  • • Ages 18 Years to 64 Years
  • • Diagnosed with haemophilia a
  • • Male only

Where?

  • • Birmingham - Queen Elizabeth Hospital, Birmingham - Haemophilia
  • • London - Royal Free Hospital - Haemophilia
  • • Sheffield - Royal Hallamshire Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Haemophilia A

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 64 Years
  • Who can join: Male only

What the study is looking for

  • ✓Age 18-64 years (both inclusive) at the time of signing the agreement to take part.
  • ✓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 (%)...

Who cannot take part

  • ✗Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal...
  • ✗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...
  • ✗Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
  • ✗Any known coagulation disorders other than haemophilia A.
See the 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.

Where Is This Study? (3 UK sites)

Queen Elizabeth Hospital, Birmingham - Haemophilia

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Royal Free Hospital - Haemophilia

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Novo Nordisk

Sponsor contact

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09