Haemophilia APhase 1VOYAGER2NCT07220564
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
A Phase 1 study testing NNC0442-0344 A in people with Haemophilia A, run by Novo Nordisk A/S at 33 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia A
- What is being tested?
- NNC0442-0344 A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 33 sitesin 12 countries
- Study dates
- 23 Oct 2025to 5 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 12 countries
Poland6 sites, 6 recruiting
- Recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
- Not yet recruiting
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-032
- Not yet recruiting
Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, 20-081
- Not yet recruiting
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 60-569
- Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
United States5 sites, 5 recruiting
- Recruiting
UC Denver Hemoph & Thrombo Ctr
Aurora, Colorado, 80045
- Recruiting
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, 17033-2360
- Recruiting
Indiana Hemophilia-Thromb Ctr
Indianapolis, Indiana, 46260
- Recruiting
University of Iowa_Iowa City
Iowa City, Iowa, 52242
- Recruiting
St Christopher Hosp for Child
Philadelphia, Pennsylvania, 19134
Spain5 sites, 3 recruiting
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
- Active, not recruiting
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
- Active, not recruiting
Hospital La Fe_Hemostasia y Trombosis
Valencia, 46026
Germany3 sites, 3 recruiting
- Recruiting
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249
- Not yet recruiting
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
- Recruiting
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie
Hanover, 30625
United Kingdom3 sites, 3 recruiting
- Recruiting
Queen Elizabeth Hospital, Birmingham - Haemophilia
Birmingham, B15 2TH
- Recruiting
Royal Free Hospital - Haemophilia
London, NW3 2QG
- Recruiting
Royal Hallamshire Hospital
Sheffield, S10 2JF
Austria2 sites, 2 recruiting
- Recruiting
Universitätsklinik für Innere Medizin V
Innsbruck, 6020
- Recruiting
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090
Italy2 sites, 2 recruiting
- Recruiting
AOU Careggi Firenze
Florence, 50134
- Recruiting
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, 80131
Portugal2 sites, 2 recruiting
- Recruiting
ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia
Porto, 4050-342
- Recruiting
ULS São João, E.P.E._H.São João_Imunohemoterapia
Porto, 4200-319
Sweden2 sites, 2 recruiting
- Recruiting
Skåne US - Koagulationsmottagning
Malmö, 214 28
- Recruiting
KS Solna - Koagulationsmottagningen
Solna, 171 64
Belgium1 site, 1 recruiting
- Not yet recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
France1 site
- Active, not recruiting
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique
Bron, 69500
Switzerland1 site, 1 recruiting
- Recruiting
Zentrum für Labormedizin
Sankt Gallen, 9008
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in 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.
- Conditions
- Haemophilia A
- Being tested
- NNC0442-0344 A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0442-0344 ADrug
Also called Inno8
NNC0442-0344 A will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
| Cohort 2 | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
| Cohort 3 | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events
Measured as count of events.
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Secondary outcomes (10)
Change in D-dimer
Measured as absolute and percentage (%).
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in fibrinogen
Measured as absolute and %.
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in platelets
Measured as absolute and %.
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Occurrence of anti-Inno8 antibodies
Measured as count.
Measured: From time of dosing (Day 1) to end of follow-up (Day 46)
Cmax: the maximum concentration of Inno8 after multiple doses
Measured as nanograms per millilitre (ng/mL).
Measured: From Day 10 to Day 11
Tmax: the time to Cmax after last multiple dose
Measured as hours.
Measured: From day 10 to Day 11
Tmax: the time to Cmax after first dose
Measured as hours.
Measured: From Day 1 to Day 2
AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Measured as nanograms*day per millilitre (ng*day/mL).
Measured: From Day 10 to Day 11
Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Measured: From Day 10 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start23 Oct 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220564
- Sponsor's protocol ID
- NN7442-8454
- Other IDs
- U1111-1317-4366, 2025-520490-38, 2025
- Acronym
- VOYAGER2
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
- ClinicalTrials.gov ID
- NCT07220564
- Acronym / sponsor ID
- VOYAGER2 / NN7442-8454
- Conditions
- Haemophilia A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NNC0442-0344 AParticipants will receive oral dose of NNC0442-0344 A. |
| Cohort 2 | Experimental | Drug: NNC0442-0344 AParticipants will receive oral dose of NNC0442-0344 A. |
| Cohort 3 | Experimental | Drug: NNC0442-0344 AParticipants will receive oral dose of NNC0442-0344 A. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0442-0344 AAlso: Inno8NNC0442-0344 A will be administered orally. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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.
10 secondary outcomes
Change in D-dimer
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in prothrombin fragment 1 and 2
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in fibrinogen
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Change in platelets
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Occurrence of anti-Inno8 antibodies
Time frame: From time of dosing (Day 1) to end of follow-up (Day 46)
Cmax: the maximum concentration of Inno8 after multiple doses
Time frame: From Day 10 to Day 11
Tmax: the time to Cmax after last multiple dose
Time frame: From day 10 to Day 11
Tmax: the time to Cmax after first dose
Time frame: From Day 1 to Day 2
AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Time frame: From Day 10 to Day 11
Maximum thrombin generation (peak height)
Time frame: From Day 10 to Day 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Haemophilia A
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
33 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0442-0344 A in people with Haemophilia A, run by Novo Nordisk A/S at 33 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Poland, United States, Spain, Germany, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (time frame: From time of dosing (Day 1) to end of follow-up (Day 46)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.