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Syringe showdown: does a prefilled device deliver drug as well as a vial?

NCT ID NCT04194892

Knowledge-focused Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether giving pegilodecakin (a biologic drug) via a prefilled syringe works the same as drawing it from a vial into a standard syringe. Healthy adults receive a single dose by each method, and researchers measure how fast the drug enters the bloodstream and how long it stays. The goal is to see if the prefilled syringe is a reliable alternative for future use.

What this could mean

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

Active substance
Pegilodecakin
What this could lead to
If the prefilled syringe works as well as the vial, it could make dosing more convenient and reduce preparation errors.
What could go wrong
This is a small, early-phase study in healthy volunteers, so results may not predict effects in patients or real-world use.

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

12 people

The number who actually took part.

Started

Jan 2018

Finished

Mar 2018

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.

Inclusion Criteria: * Must have a body mass index (BMI) between 19.0 and 32.0 kilograms per meter squared (kg/m²) at study screening * Must be Human Immunodeficiency Virus (HIV) negative by HIV 1/0/2 testing. * Must be Hepatitis B (HBV) surface antigen negative * Must be Hepatitis C (HCV) antibody negative * Females must have a negative serum pregnancy test Exclusion Criteria: * Pregnant or lactating subjects * Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing * Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance * Have smoked or used tobacco/nicotine products within 90 days prior to the study dosing * Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) * Have been vaccinated within 90 days of study dosing

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As listed by the trial registrant

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

Healthy adult subjects

Contacts and locations

Locations

  • PPD Phase 1 Clinic

    Austin, Texas, 78744, United States

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