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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: Pegilodecakin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegilodecakin Vial<br>Pegilodecakin administered subcutaneously (SQ) in one of two study periods. | Biological: Pegilodecakin<br>* Administered SQ<br>* Other names: AM0010;|
| Experimental: Pegilodecakin Pre-filled syringe (PFS)<br>Pegilodecakin administered SQ in one of two study periods. | Biological: Pegilodecakin<br>* Administered SQ<br>* Other names: AM0010;|

What is the study measuring?
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Primary Outcome Measures

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