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NCT07220564RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
22 Oct 2025
Start date
23 Oct 2025
Primary completion date
5 Feb 2027
Lead sponsor
Novo Nordisk A/S
Diseases
Haemophilia
NCT number
NCT07220564
EU CT number
2025-520490-38-00
EudraCT number
2025-520490-38

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From 23 Oct 2025 to the primary completion date, 5 Feb 2027
  • 33 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
  • Ongoing or planned immune tolerance induction therapy.

Other illness

  • 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.
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Other

  • Body mass index ≥30.0 kilogram per square meter (kg/m\^2).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumNot yet recruiting
Zentrum für Labormedizin
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Sankt GallenSwitzerlandRecruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospices Civils de Lyon
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BronFranceCompleted
Queen Elizabeth Hospital, Birmingham - Haemophilia
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BirminghamUnited KingdomRecruiting
Royal Free Hospital - Haemophilia
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LondonUnited KingdomRecruiting
Royal Hallamshire Hospital
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SheffieldUnited KingdomRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyCompleted
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandCompleted
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandCompleted
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandCompleted
Instytut Hematologii I Transfuzjologii
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WarsawPolandCompleted
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalActive, not recruiting
Region Skane Skanes Universitetssjukhus
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MalmoSwedenActive, not recruiting
Karolinska University Hospital
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SolnaSwedenActive, not recruiting
UC Denver Hemoph & Thrombo Ctr
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AuroraUnited StatesRecruiting
Penn State MS Hershey Med Ctr
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HersheyUnited StatesRecruiting
Indiana Hemophilia-Thromb Ctr
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IndianapolisUnited StatesRecruiting
University Of Iowa_Iowa City
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Iowa CityUnited StatesRecruiting
St Christopher Hosp for Child
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PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.