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Needle-Free drug delivery tested in healthy volunteers

NCT ID NCT06741657

Knowledge-focused Sponsor: Biogen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study tested whether giving the drug litifilimab under the skin using an autoinjector or a wearable on-body injector works as well as using a traditional syringe. 404 healthy volunteers received the drug by one of the three devices. Researchers measured drug levels in the blood and checked for side effects and injection site pain. The goal was to see if these automatic devices could be a good alternative for patients who have trouble using syringes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
litifilimab (BIIB059)
What this could lead to
If successful, this could make it easier for patients to receive litifilimab at home using automatic injectors instead of syringes.
What could go wrong
This is an early-phase study in healthy people, not patients. It only checks how the drug moves through the body, not whether it works for 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

404 people

The number who actually took part.

Started

Jan 2025

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 55 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.

Key Inclusion Criteria * Must have a body mass index between 18.5 and 30 kilograms per square meter (kg/m\^2), and a body weight ≥ 50 kg to ≤ 100 kg. * Must be in good health as determined by the investigator, based on medical history physical examination, electrocardiogram (ECG), and other screening evaluations. Key Exclusion Criteria * History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the investigator. * A positive diagnostic tuberculosis test result within 4 weeks prior to Enrollment (Day 1), defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results. * History or positive test result for human immunodeficiency virus (HIV). * History of severe herpes infection such as herpetic encephalitis, ophthalmic herpes, or disseminated herpes. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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As listed by the trial registrant

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

Healthy volunteer

Contacts and locations

Locations

  • Austin Clinical Research Unit

    Austin, Texas, 78744, United States

  • Las Vegas Clinical Research Unit

    Las Vegas, Nevada, 89113, United States

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