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New pen injector for hemophilia drug tested in healthy men

NCT ID NCT05681845

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether a new pen injector delivers the drug Mim8 into the blood as well as a standard syringe and cartridge. 205 healthy men received a single injection of Mim8 using either the pen or the syringe. The goal was to see if the pen works just as well, making it easier for people with hemophilia A to take their medicine. Participants were not treated for hemophilia A, as they were healthy volunteers.

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

205 people

The number who actually took part.

Started

Jan 2023

Finished

Oct 2023

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 55 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 aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 18.5 and 29.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening. * Body weight between 60.0 and 100.0 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: * 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. * Factor VIII activity greater than or equal to (≥) 150 percent (%) at screening. * Thrombophilia as identified by any of the below laboratory markers at screening: * Protein C, protein S or antithrombin less than (\<) lower limit of normal (LLN) * Factor II activity or activated protein C resistance \>upper limit of normal (ULN).

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A

Contacts and locations

Locations

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.