A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Adult Subjects
In brief
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.
Key facts
- Study ID
- NCT04194892
- Run by
- Eli Lilly and Company
- People needed
- 12
- Starts
- 2018-01-19
- Expected to finish
- 2018-03-14
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- PPD Phase 1 Clinic — Austin, Texas, United States
Full record on ClinicalTrials.gov
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