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

NCT04840901 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17955J2T-MC-KGBG
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab

  PK: Cmax of Lebrikizumab

  Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab

  PK: AUC\[0-∞\] of Lebrikizumab

  Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

• 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: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Lebrikizumab

Lebrikizumab (Test) - Autoinjector

EXPERIMENTAL

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

Drug: Lebrikizumab

Interventions

Lebrikizumab DRUG

Administered SC.

Also known as: LY3650150

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

LabCorp CRU, Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

lebrikizumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-595-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 12, 2021
• Study Start: June 2, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)