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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840901

J2T-MC-KGBG (Other Identifier)

17955

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device

Experimental group

Description:

2-milliliter (mL) (125 milligrams per milliliter \[mg/mL\]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).

Treatment:

Drug: Lebrikizumab

Lebrikizumab (Test) - Autoinjector

Experimental group

Description:

2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).

Treatment:

Drug: Lebrikizumab