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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A (NCT07220564) is a Phase 1 interventional studying Haemophilia A, sponsored by Novo Nordisk A/S. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Haemophilia A, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male - Age 18-64 years (both inclusive) at the time of signing the willing to sign a consent form. - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

NNC0442-0344 A

NNC0442-0344 A will be administered orally.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, United States
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, United States
University of Iowa_Iowa City
Iowa City, Iowa, United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
Universitätsklinik für Innere Medizin V
Innsbruck, Austria
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
Bron, France
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, Germany
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover, Germany
AOU Careggi Firenze
Florence, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07220564), the sponsor (Novo Nordisk A/S), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07220564 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07220564?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07220564?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07220564. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07220564. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.