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

• Lebrikizumab (Drug), also known as LY3650150: Administered SC.

Primary outcomes

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab [Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99]: PK: Cmax of Lebrikizumab
• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab [Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99]: 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: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99]: PK: AUC\[0-tlast\] of Lebrikizumab

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab (Primary), Geometric mean, micrograms per milliliter (µg/mL): Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 38.5 +/- 31; Lebrikizumab (Test) - Autoinjector (AI) 41.9 +/- 31
• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab (Primary), Geometric mean, micrograms*day per milliliter (µg*d/mL): Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 1340 +/- 29; Lebrikizumab (Test) - Autoinjector (AI) 1450 +/- 26
• PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab (Primary), Geometric mean, µg*d/mL: Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 1250 +/- 28; Lebrikizumab (Test) - Autoinjector (AI) 1360 +/- 25

Adverse events

Time frame: Up to 99 days

Other adverse events by term

3 more terms not shown.

• Study Protocol (PDF, 2021-08-17)
• Statistical Analysis Plan (PDF, 2022-03-09)

• 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), Study director, Eli Lilly and Company