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Healthy volunteers test two injection devices for drug delivery

NCT ID NCT06475729

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how well two different autoinjectors deliver the drug mirikizumab into the bloodstream of healthy people. About 500 healthy adults received a single injection under the skin using either a standard 1-mL autoinjector or a newer 2-mL version. The goal was to see if the two devices work the same way, not to treat any disease.

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

498 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 2024

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 65 years

Sex

Anyone

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: Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: * Medical history, * Physical examination, * Clinical laboratory tests, * Electrocardiogram (ECG), * Vital signs Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data. 2. Have clinical laboratory test results: * Within normal reference range for the population, or * Within normal reference range for the investigative site, or * Results with acceptable deviations that are judged to be not clinically significant by the investigator. Weight 3. Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m\^2), inclusive. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Medical conditions 4. Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation. 5. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data. 6. Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. 7. Have a diagnosis or history of malignant disease within 5 years prior to baseline. Prior/concomitant therapy 8. Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing. 9. Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing. 10. Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use. 11. Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization. Prior/concurrent clinical study experience 12. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. 13. Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing. 14. Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab. Diagnostic assessments 15. Have a current infection with hepatitis C virus. 16. Have a current infection with hepatitis B virus. 17. Have a current or recent acute, active infection. 18. Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization: 1. Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both. 2. Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. 3. Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer. 4. Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis. 19. Show evidence of active or latent tuberculosis (TB). Other exclusion criteria 20. Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator. 21. Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions. 22. In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • CenExel ACT

    Anaheim, California, 92801, United States

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014-3616, United States

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida, 32117, United States

  • Fortrea Clinical Research Unit

    Dallas, Texas, 75247, United States

  • Fortrea Clinical Research Unit

    Madison, Wisconsin, 53704, United States

  • QPS Missouri

    Springfield, Missouri, 65802, United States

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