Haemophilia APhase 1VOYAGER1NCT06649630

A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men

A Phase 1 study testing NNC0442-0344 A in people with Haemophilia A, run by Novo Nordisk A/S at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 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, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 2 sitesGermany
Study dates: 23 Sep 2024to 26 Mar 2026
Phase: Phase 1
Are there results?: None posted in the registry

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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male
Age 18-45 years (both inclusive) at the time of signing informed consent
Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive)
Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Who cannot join

Factor VIII activity greater than or equal to (≥) 150% at screening
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 of the thrombophilia markers listed below:
Protein C, protein S or antithrombin below the lower normal laboratory range
Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117
Charité Research Organisation GmbH
Berlin, 10117

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants

This study will test how different doses of study medicine (Inno8) work in the healthy men. The purpose of this study is to prove safety of Inno8 in healthy men, which will support further development of Inno8 in people with Haemophilia A. The study consists of three parts: single ascending dose (SAD), multiple ascending dose (MAD) and single subcutaneous dose (SSD). Each part will have more than one cohort (like sub-parts). No matter which part the participants will be enrolled in, they will either get the study medicine (Inno8) or a dummy medicine that looks like the study medicine but has no effect on the body (placebo). Which treatment participants get is decided by chance. The study medicine is a new medicine that cannot be prescribed by doctors. In the SAD and SSD part participants will receive a single injection of study medicine or placebo, and the study will last for up to 9 weeks. In the MAD part, participants will receive 1-2 tablets of study medicine or placebo daily for 10 days, and the study will last for up to 11 weeks.

Conditions: Haemophilia A
Being tested: NNC0442-0344 A, Placebo
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
SAD: NNC0442-0344 A will be administered intravenously.
MAD: NNC0442-0344 A will be administered orally.
SSD: NNC0442-0344 A will be administered subcutaneously.
PlaceboDrug
SAD: Placebo will be administered intravenously.
MAD: Placebo will be administered orally.
SSD: Placebo will be administered subcutaneously.

Study groups in NCT06649630
Study group	Role	What they receive
Cohort 1 (SAD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A intravenously. Receives: Drug: NNC0442-0344 A
Cohort 2 (SAD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A intravenously. Receives: Drug: NNC0442-0344 A
Cohort 3 (SAD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A intravenously. Receives: Drug: NNC0442-0344 A
Cohort 4 (SAD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A intravenously. Receives: Drug: NNC0442-0344 A
Cohort 5 (SAD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A intravenously. Receives: Drug: NNC0442-0344 A
Cohort 1 (MAD): NNC0442-0344 A	Experimental	Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Receives: Drug: NNC0442-0344 A
Cohort 2 (MAD): NNC0442-0344 A	Experimental	Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Receives: Drug: NNC0442-0344 A
Cohort 3 (MAD): NNC0442-0344 A	Experimental	Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Receives: Drug: NNC0442-0344 A
Cohort 4 (MAD): NNC0442-0344 A	Experimental	Participants will receive a oral daily dose of NNC0442-0344 A for 10 days. Receives: Drug: NNC0442-0344 A
Cohort 1 (SSD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A subcutaneously. Receives: Drug: NNC0442-0344 A
Cohort 2 (SSD): NNC0442-0344 A	Experimental	Participants will receive single dose of NNC0442-0344 A subcutaneously. Receives: Drug: NNC0442-0344 A
SAD: Placebo	Placebo comparator	Participants will receive single dose of placebo intravenously. Receives: Drug: Placebo
MAD: Placebo	Placebo comparator	Participants will receive a oral daily dose of Placebo for 10 days. Receives: Drug: Placebo
SSD: Placebo	Placebo comparator	Participants will receive single dose of placebo subcutaneously. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

SAD: Number of treatment emergent adverse events
Measured as count of events.
Measured: From time of dosing (Day 1) to Day 36
MAD: 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)
SSD: Number of treatment emergent adverse events
Measured as count of events.
Measured: From time of dosing (Day 1) to Day 36

Secondary outcomes (28)

SAD: Change in D-dimer
Measured as absolute and percentage (%).
Measured: From baseline (Day 1) to Day 36
SAD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SAD: Change in fibrinogen
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SAD: Change in platelets
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Measured as nanograms per millilitre (ng/mL).
Measured: From baseline (Day 1) to Day 36
SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Measured as nanograms*day per millilitre (ng*day/mL).
Measured: From baseline (Day 1) to Day 36
SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Measured as days.
Measured: From baseline (Day 1) to Day 36
SAD: Maximum change in activated partial thromboplastin time
Measured as seconds.
Measured: From baseline (Day 1) to Day 36
SAD: Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Measured: From baseline (Day 1) to Day 36
MAD: Change in D-dimer
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 46
MAD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 46
MAD: Change in fibrinogen
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 46
MAD: Change in platelets
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 46
MAD: Occurrence of anti-Inno8 antibodies
Measured as count.
Measured: From baseline (Day 1) to Day 46
MAD: Cmax: The maximum concentration of Inno8 after multiple doses
Measured as ng/mL.
Measured: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after last multiple dose
Measured as hours.
Measured: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after first dose
Measured as hours.
Measured: From Day 1 to Day 2
MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Measured as ng*day/mL.
Measured: From Day 10 to Day 11
MAD: Maximum thrombin generation (peak height)
Measured as nM.
Measured: From Day 10 to Day 11
SSD: Change in D-dimer
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SSD: Change in prothrombin fragment 1 and 2
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SSD: Change in fibrinogen
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SSD: Change in platelets
Measured as absolute and %.
Measured: From baseline (Day 1) to Day 36
SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Measured as ng/mL.
Measured: From baseline (Day 1) to Day 36
SSD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Measured as ng*day/mL.
Measured: From baseline (Day 1) to Day 36
SSD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Measured as days.
Measured: From baseline (Day 1) to Day 36
SSD: Maximum change in activated partial thromboplastin time
Measured as seconds.
Measured: From baseline (Day 1) to Day 36
SSD: Maximum thrombin generation (peak height)
Measured as nanomolar (nM).
Measured: From baseline (Day 1) to Day 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202426 Mar 2026

First posted21 Oct 2024
Study start23 Sep 2024
Primary completion26 Mar 2026
Study completion26 Mar 2026

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06649630
Sponsor's protocol ID: NN7442-7582
Other IDs: U1111-1292-7153, 2023-506520-90, 2023
Acronym: VOYAGER1
Status last verified: Mar 2026
First submitted: 14 Oct 2024
Last updated: 1 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Haemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous, Oral and Subcutaneous Doses of Inno8 in Healthy Male Participants
ClinicalTrials.gov ID: NCT06649630
Acronym / sponsor ID: VOYAGER1 / NN7442-7582
Conditions: Haemophilia A
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 23 Sep 2024 (actual)
Primary completion: 26 Mar 2026 (actual)
Study completion: 26 Mar 2026 (actual)
First posted: 21 Oct 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 14

Arm	Type	Receives
Cohort 1 (SAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 2 (SAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 3 (SAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 4 (SAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 5 (SAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 1 (MAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 2 (MAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 3 (MAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 4 (MAD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 1 (SSD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A subcutaneously.
Cohort 2 (SSD): NNC0442-0344 A	Experimental	Drug: NNC0442-0344 AParticipants will receive single dose of NNC0442-0344 A subcutaneously.
SAD: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive single dose of placebo intravenously.
MAD: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a oral daily dose of Placebo for 10 days.
SSD: Placebo	Placebo comparator	Drug: PlaceboParticipants will receive single dose of placebo subcutaneously.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male
Age 18-45 years (both inclusive) at the time of signing informed consent
Body mass index between 18.5 and 29.9 Kilogram Per Square Meter (kg/m^2) (both inclusive)
Body weight between 60.0 and 100.0 Kilogram (kg) (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Key exclusion criteria (6 listed)

Factor VIII activity greater than or equal to (≥) 150% at screening
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 of the thrombophilia markers listed below:
Protein C, protein S or antithrombin below the lower normal laboratory range

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: Inno8SAD: NNC0442-0344 A will be administered intravenously. MAD: NNC0442-0344 A will be administered orally. SSD: NNC0442-0344 A will be administered subcutaneously.	Drug	Cohort 1 (MAD): NNC0442-0344 A, Cohort 1 (SAD): NNC0442-0344 A, Cohort 1 (SSD): NNC0442-0344 A, Cohort 2 (MAD): NNC0442-0344 A, Cohort 2 (SAD): NNC0442-0344 A, Cohort 2 (SSD): NNC0442-0344 A, Cohort 3 (MAD): NNC0442-0344 A, Cohort 3 (SAD): NNC0442-0344 A, Cohort 4 (MAD): NNC0442-0344 A, Cohort 4 (SAD): NNC0442-0344 A, Cohort 5 (SAD): NNC0442-0344 A
PlaceboSAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.	Drug	MAD: Placebo, SAD: Placebo, SSD: Placebo

Primary outcome

SAD: Number of treatment emergent adverse events
Time frame: From time of dosing (Day 1) to Day 36
Measured as count of events.
MAD: 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.
SSD: Number of treatment emergent adverse events
Time frame: From time of dosing (Day 1) to Day 36
Measured as count of events.

28 secondary outcomes

SAD: Change in D-dimer
Time frame: From baseline (Day 1) to Day 36
SAD: Change in prothrombin fragment 1 and 2
Time frame: From baseline (Day 1) to Day 36
SAD: Change in fibrinogen
Time frame: From baseline (Day 1) to Day 36
SAD: Change in platelets
Time frame: From baseline (Day 1) to Day 36
SAD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SAD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SAD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SAD: Maximum change in activated partial thromboplastin time
Time frame: From baseline (Day 1) to Day 36
SAD: Maximum thrombin generation (peak height)
Time frame: From baseline (Day 1) to Day 36
MAD: Change in D-dimer
Time frame: From baseline (Day 1) to Day 46
MAD: Change in prothrombin fragment 1 and 2
Time frame: From baseline (Day 1) to Day 46
MAD: Change in fibrinogen
Time frame: From baseline (Day 1) to Day 46
MAD: Change in platelets
Time frame: From baseline (Day 1) to Day 46
MAD: Occurrence of anti-Inno8 antibodies
Time frame: From baseline (Day 1) to Day 46
MAD: Cmax: The maximum concentration of Inno8 after multiple doses
Time frame: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after last multiple dose
Time frame: From Day 10 to Day 11
MAD: Tmax: The time to Cmax after first dose
Time frame: From Day 1 to Day 2
MAD: AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses
Time frame: From Day 10 to Day 11
MAD: Maximum thrombin generation (peak height)
Time frame: From Day 10 to Day 11
SSD: Change in D-dimer
Time frame: From baseline (Day 1) to Day 36
SSD: Change in prothrombin fragment 1 and 2
Time frame: From baseline (Day 1) to Day 36
SSD: Change in fibrinogen
Time frame: From baseline (Day 1) to Day 36
SSD: Change in platelets
Time frame: From baseline (Day 1) to Day 36
SSD: Cmax, SD: the maximal concentration of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SSD: AUC, SD: the area under the concentration curve of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SSD: T1/2, SD: the terminal half-life of Inno8 after a single dose
Time frame: From baseline (Day 1) to Day 36
SSD: Maximum change in activated partial thromboplastin time
Time frame: From baseline (Day 1) to Day 36
SSD: Maximum thrombin generation (peak height)
Time frame: From baseline (Day 1) to Day 36

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Haemophilia A

Not yet recruitingPhase 1
Lentiviral FVIII Gene Therapy
Hemophilia A
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
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An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia 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. This study is not recruiting at the moment.

Clinical Transparency (dept. 2834) study director

Novo Nordisk A/S

2 sites in 1 country: 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 2 sites in Germany.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAD: Number of treatment emergent adverse events (time frame: From time of dosing (Day 1) to Day 36). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649630.

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 1 Apr 2026.