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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04840901
Collaborator
(none)
240
Enrollment
4
Locations
2
Arms
7.7
Anticipated Duration (Months)
60
Patients Per Site
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Jun 2, 2021
Anticipated Primary Completion Date :
Jan 22, 2022
Anticipated Study Completion Date :
Jan 22, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Lebrikizumab - Pre-Filled Syringe with Needle Safety Device

Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).

Drug: Lebrikizumab
Administered SC.
Other Names:
  • LY3650150
  • Experimental: Lebrikizumab - Autoinjector

    Lebrikizumab administered SC via autoinjector (AI).

    Drug: Lebrikizumab
    Administered SC.
    Other Names:
  • LY3650150
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab [Predose up to 99 days postdose]

      PK: (Cmax) of Lebrikizumab

    2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab [Predose up to 99 days postdose]

      PK: AUC[0-∞] of Lebrikizumab

    3. PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab [Predose up to 99 days postdose]

      PK: AUC[0-tlast] of Lebrikizumab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1LabCorp CRU, Inc.Daytona BeachFloridaUnited States32117
    2QPSSpringfieldMissouriUnited States65802
    3Covance DallasDallasTexasUnited States75247
    4LabCorp CRU, Inc.MadisonWisconsinUnited States53704

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04840901
    Other Study ID Numbers:
    • 17955
    • J2T-MC-KGBG
    First Posted:
    Apr 12, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 15, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 18, 2021