Healthy volunteers compare two methods of delivering navenibart
NCT ID NCT07635095
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial in 180 healthy adults compares two ways of giving the drug navenibart: by autoinjector or by vial and syringe. The goal is to see if both methods lead to similar drug levels in the blood and have similar safety. Participants receive one dose and are monitored in the clinic and during follow-up visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- navenibart
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
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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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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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 55 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.
Key Inclusion Criteria: * Males and females 18 to 55 years of age * In good health, as determined by the Investigator * Written informed consent, including confirmation of willingness to comply with all trial procedures * Body weight between 50 and 100 kg, and body mass index (BMI) between 18 and 30 kg/m\^2 * Has not previously received navenibart * Not pregnant or breastfeeding and agreement to comply with requirements for pregnancy and breastfeeding, contraception use, and egg donation for the specified periods. Key Exclusion Criteria: * Prior or ongoing medical history, or results of a medical assessment, that the Investigator feels could result in a risk to the safety of the participant or the quality of data from the trial. * Key laboratory results outside of defined ranges * History or positive test results for tobacco, nicotine products, alcohol, marijuana (cannabis), or drugs of abuse * Receipt of other prohibited medications, biologic medications, or investigational products within defined windows prior to dosing * History of severe allergic reactions with an unknown cause * Donation of blood (at least 500 mL), or any amount of platelets or plasma within defined windows prior to dosing. * Known hypersensitivity to any component of navenibart * Any condition that the Investigator feels may affect the ability to provide written informed consent or demonstrates unwillingness or inability to comply with trial procedures
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Fortrea Clinical Trials
RECRUITINGDaytona Beach, Florida, 32117, United States
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Fortrea Clinical Trials
RECRUITINGDallas, Texas, 75247, United States
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Fortrea Clinical Trials
RECRUITINGMadison, Wisconsin, 53704, United States
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