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

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Dose Bioequivalence Study of Injections of Lebrikizumab Using a 2-mL Pre-Filled Syringe With Needle Safety Device and an Investigational 2-mL Autoinjector in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840901
• Other study ID #: 17955
• Secondary ID: J2T-MC-KGBG
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: May 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lebrikizumab
Administered SC.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida
United States	LabCorp CRU, Inc.	Madison	Wisconsin
United States	QPS	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab	PK: (Cmax) of Lebrikizumab	Predose up to 99 days postdose
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Lebrikizumab	PK: AUC[0-8] of Lebrikizumab	Predose up to 99 days postdose
Primary	PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab	PK: AUC[0-tlast] of Lebrikizumab	Predose up to 99 days postdose