A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants (Willow 3)

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Pegilodecakin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04194892

J1L-AM-JZGG (Other Identifier)

17299

AM0010-803 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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