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New haemophilia drug Inno8 tested in healthy volunteers

NCT ID NCT06649630

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117, Germany

  • Charité Research Organisation GmbH

    Berlin, 10117, Germany

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