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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lebrikizumab

• Registration Number: NCT04840901
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-12
• Study Start: 2021-06-02
• Primary Completion: 2022-02-11
• Study Completion: 2022-02-11
• Status Verified: 2024-09
• Results First Submitted: 2024-09-26
• Results First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Results First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device	Lebrikizumab	2-milliliter (mL) (125 milligrams per milliliter \[mg/mL\]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).
Lebrikizumab (Test) - Autoinjector	Lebrikizumab	2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

QPS; 🇺🇸 Springfield, Missouri, United States

LabCorp CRU, Inc.; 🇺🇸 Madison, Wisconsin, United States

Covance Dallas; 🇺🇸 Dallas, Texas, United States