Haemophilia APhase 1NCT07238816
A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People
A Phase 1 study testing NNC0442-0344 A in people with Haemophilia A, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. Read more about this study
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to 8 May 2026
- Phase
- Phase 1
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) at screening.
- Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.
- 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 percentage (%) 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:
- Lupus anticoagulant, anti-cardiolipin antibody Immunoglobulin G (IgG) and Immunoglobulin M (IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening.
- Heterozygosity or homozygosity for the factor V Leiden mutation (G1691A) OR heterozygosity or homozygosity for the prothrombin mutation (G20210A) OR compound heterozygosity for the factor V Leiden (G1691A) and prothrombin mutation (G20210A).
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- Protein C, protein S or antithrombin below the lower normal laboratory range.
- Any known coagulation disorders.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical LA, Inc.
Cypress, California, 90630
About this study
Official title: A Single-centre, Open-label, Randomised, Single-dose Study to Evaluate the Effect of Pre- and Post-dose Meal Timings on the Pharmacokinetic Properties of Inno8 in Healthy Participants
The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 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 |
|---|---|---|
| Group A | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
| Group B | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
| Group C | Experimental | Participants will receive oral dose of NNC0442-0344 A. Receives: Drug: NNC0442-0344 A |
| Reference dose | Active comparator | 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.
AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
Measured as nanograms*day per millilitre (ng*day/mL).
Measured: From baseline (Day 1) to day 17
Secondary outcomes (9)
Cmax: Maximum observed plasma Inno8 concentration after a single oral dose
Measured as nanograms per millilitre (ng/mL).
Measured: From baseline (Day 1) to day 17
Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose
Measured as hours.
Measured: From baseline (Day 1) to day 17
Number of treatment emergent adverse events
Measured as count of events.
Measured: From time of dosing (Day 1) to day 36
Change in D-dimer
Measured as absolute (ng/mL) and percentage (%).
Measured: From baseline (Day 1) to day 36
Change in prothrombin fragment 1 and 2
Measured as absolute [(picomoles per litre) pmol/L] and %.
Measured: From baseline (Day 1) to day 36
Change in fibrinogen
Measured as absolute [(milligrams per decilitre) mg/dL] and %.
Measured: From baseline (Day 1) to day 36
Change in platelets
Measured as absolute [(ten to the ninth power per litre) 10^9/L] and %.
Measured: From baseline (Day 1) to day 36
Change in FIX antigen
Measured as %.
Measured: From baseline (Day 1) to day 36
Change in FX antigen
Measured as %.
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.
- First posted20 Nov 2025
- Study start18 Nov 2025
- Primary completion8 May 2026
- Study completion8 May 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
- None (open label)
- Enrolment
- 80 participants (actual)
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
- NCT07238816
- Sponsor's protocol ID
- NN7442-8255
- Other IDs
- Universal Trial Number
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2025
- Last updated
- 17 Jun 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