A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lebrikizumab - Pre-Filled Syringe with Needle Safety Device Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). |
Drug: Lebrikizumab
Administered SC.
Other Names:
|
Experimental: Lebrikizumab - Autoinjector Lebrikizumab administered SC via autoinjector (AI). |
Drug: Lebrikizumab
Administered SC.
Other Names:
|
Outcome Measures
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
Eligibility Criteria
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
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Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
Exclusion Criteria:
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Are females who are pregnant or lactating.
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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
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Have a history or presence of psychiatric disorders
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Show evidence of human immunodeficiency virus infection.
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Show evidence of hepatitis C and/or hepatitis B
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Medical history of allergic reaction to humanized monoclonal antibodies
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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.
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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.
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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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | LabCorp CRU, Inc. | Daytona Beach | Florida | United States | 32117 |
2 | QPS | Springfield | Missouri | United States | 65802 |
3 | Covance Dallas | Dallas | Texas | United States | 75247 |
4 | LabCorp CRU, Inc. | Madison | Wisconsin | United States | 53704 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- 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.More Information
Publications
None provided.- 17955
- J2T-MC-KGBG