NCT04840901

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lebrikizumab	Administered SC.

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-02-11
• Completion: 2022-02-11
• First posted: 2021-04-12
• Last updated: 2024-11-22
• Results posted: 2024-11-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study