Timing your meals could make this hemophilia drug work better
NCT ID NCT07238816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medicine called Inno8 for hemophilia A. Researchers want to see how eating and drinking before and after taking the pill changes how much medicine gets into the blood. 80 healthy men aged 18-45 will take one dose after fasting, then wait different times before eating again. The results will help doctors give the best dosing instructions for people with hemophilia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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80 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Altasciences Clinical LA, Inc.
Cypress, California, 90630, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Japanese hemophilia patients monitored on alhemo in new safety study
- New hope for haemophilia a patients: immune tolerance induction may eliminate clotting factor blockers