A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase 1, Open-Label, Single-Dose Bioequivalence Study of Injections of Lebrikizumab Using a 2-mL Pre-Filled Syringe With Needle Safety Device and an Investigational 2-mL Autoinjector in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lebrikizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device<br>2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). | Drug: Lebrikizumab<br>* Administered SC.<br>* Other names: LY3650150;|
| Experimental: Lebrikizumab (Test) - Autoinjector<br>2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). | Drug: Lebrikizumab<br>* Administered SC.<br>* Other names: LY3650150;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab | PK: (Cmax) of Lebrikizumab | Predose up to 99 days postdose | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | PK: AUC[0-∞] of Lebrikizumab | Predose up to 99 days postdose | 
| PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | PK: AUC[0-tlast] of Lebrikizumab | Predose up to 99 days postdose |