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OpenTrials
Completed

NCT Number: NCT04194892

A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants

The purpose of this study is to assess how fast pegilodecakin gets into the blood stream and how long it takes the body to remove it, when given as a solution formulation via a prefilled syringe (PFS) versus from a vial drawn into a conventional syringe. Information about side effects will be collected. The study is open to healthy participants. Total participant duration in trial is approximately 42 days.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegilodecakin

Biological

Administered SQ

Other names: LY3500518, AM0010

Primary outcomes

  1. Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin

    Time frame: Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)

    Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin.

  2. PK: Time of Maximum Concentration (Tmax) of Pegilodecakin

    Time frame: Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)

    Time of maximum serum concentration (Tmax) of Pegilodecakin.

  3. PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin

    Time frame: Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)

    PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ARMO BioSciences

Registry information

Official study title

An Open Label, Randomized, Single Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics of Pre-filled Syringe Versus Vial Formulations of AM0010 in Healthy Adult Subjects

Acronym: Willow 3

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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