New haemophilia drug Inno8 tested in healthy volunteers
NCT ID NCT06649630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial tested the safety of a new drug called Inno8 in 95 healthy men. Participants received either Inno8 or a placebo by injection or as tablets. The study measured side effects and how the drug moves through the body. Results will help decide if Inno8 should be tested further in people with haemophilia A.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inno8 (NNC0442-0344 A)
- What this could lead to
- If this early safety trial succeeds, it could support further development of Inno8 as a potential treatment for haemophilia A.
- What could go wrong
- This is a very early Phase 1 trial in only 95 healthy men, not people with haemophilia. It is designed only to check safety and dosing, not to prove the drug works. Many drugs fail in later stages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
95 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
Mar 2026
- Lead sponsor
-
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
-
18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
-
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) * 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 Exclusion Criteria: * 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
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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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Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117, Germany
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Charité Research Organisation GmbH
Berlin, 10117, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lab-made antibody stop bleeding in a rare blood disorder?
- Can an ultra-long-acting factor VIII simplify surgery for hemophilia a patients?
- Patient voices take center stage in haemophilia a treatment decisions
- Japanese study tracks Esperoct's Real-World safety over two years
- Japanese hemophilia patients monitored on alhemo in new safety study
- New hope for haemophilia a patients: immune tolerance induction may eliminate clotting factor blockers