A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be evaluated. The study will last up to 102 days.
Arms and Interventions
|Experimental: Lebrikizumab - Pre-Filled Syringe with Needle Safety Device|
Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).
|Experimental: Lebrikizumab - Autoinjector|
Lebrikizumab administered SC via autoinjector (AI).
Primary Outcome Measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab [Predose up to 99 days postdose]
PK: (Cmax) of Lebrikizumab
- PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab [Predose up to 99 days postdose]
PK: AUC[0-∞] of Lebrikizumab
- PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab [Predose up to 99 days postdose]
PK: AUC[0-tlast] of Lebrikizumab
Are Overtly healthy males or nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation.
Agree not to donate blood or plasma until after the end of their participation in the study
Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
Are females who are pregnant or lactating.
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Have a history or presence of psychiatric disorders
Show evidence of human immunodeficiency virus infection.
Show evidence of hepatitis C and/or hepatitis B
Medical history of allergic reaction to humanized monoclonal antibodies
Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or are unable to abide by CRU smoking restrictions
Contacts and Locations
|1||LabCorp CRU, Inc.||Daytona Beach||Florida||United States||32117|
|3||Covance Dallas||Dallas||Texas||United States||75247|
|4||LabCorp CRU, Inc.||Madison||Wisconsin||United States||53704|
Sponsors and Collaborators
- Eli Lilly and Company
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)None provided.