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

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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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Pegilodecakin Vial
Experimental group
Description:
Pegilodecakin administered subcutaneously (SQ) in one of two study periods.
Treatment:
Biological: Pegilodecakin
Pegilodecakin Pre-filled syringe (PFS)
Experimental group
Description:
Pegilodecakin administered SQ in one of two study periods.
Treatment:
Biological: Pegilodecakin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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