Healthy volunteers test two injection devices for drug delivery
NCT ID NCT06475729
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.
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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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498 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Dec 2024
- 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 65 years
- Sex
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Anyone
- 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: 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
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CenExel ACT
Anaheim, California, 92801, United States
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Clinical Pharmacology of Miami
Miami, Florida, 33014-3616, United States
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Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117, United States
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Fortrea Clinical Research Unit
Dallas, Texas, 75247, United States
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Fortrea Clinical Research Unit
Madison, Wisconsin, 53704, United States
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QPS Missouri
Springfield, Missouri, 65802, United States
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