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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-02

Study Completion Date

2022-02-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Administered SC.

Lebrikizumab (Test) - Autoinjector

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

Group Type EXPERIMENTAL

Lebrikizumab

Intervention Type DRUG

Administered SC.

Interventions

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Lebrikizumab

Administered SC.

Intervention Type DRUG

Other Intervention Names

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LY3650150

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes