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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04194892

Acronym

Willow 3

Enrollment

Registered

2019-12-11

Start date

2018-01-19

Completion date

2018-03-14

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

BIOLOGICALPegilodecakin

Administered SQ

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin	Predose through approximately 14 days postdose	Cmax of Pegilodecakin
PK: Time of Maximum Concentration (Tmax)	Predose through approximately 14 days postdose	Tmax of Pegilodecakin
PK: Area Under the Serum Concentration Versus Time Curve (AUC)	Predose through approximately 14 days postdose	AUC of Pegilodecakin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026