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Healthy volunteers help unlock the Body's handling of a new drug

NCT ID NCT03381547

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates how the drug pegilodecakin is absorbed and cleared from the body when given as a single injection at different doses and in different formulations. It involves 12 healthy adults aged 18 to 55. The goal is to measure key drug levels in the blood to guide future dosing decisions.

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 successful, this study could help determine the right dose and formulation of pegilodecakin for future trials in patients.
What could go wrong
This is an early-phase study in only 12 healthy people, so results may not predict effects in patients or guarantee safety or efficacy.

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

Dec 2017

Finished

Feb 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: 1. Male or female between 18 and 55 years of age, inclusive 2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening 3. Must be HIV negative by HIV 1/0/2 testing 4. Must be Hepatitis B (HBV) surface antigen negative 5. Must be Hepatitis C (HCV) antibody negative 6. Females must have a negative serum pregnancy test 7. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug. 8. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug Exclusion Criteria: 1. Pregnant or lactating subjects 2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing 3. Have poor venous access and are unable to donate blood 4. Have been vaccinated within 90 days of study dosing 5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance 6. Have history of significant drug sensitivity or drug allergy.

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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 Development

    Austin, Texas, 78744, United States

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