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A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT05069896
Collaborator
(none)
237
Enrollment
3
Locations
2
Arms
8.5
Actual Duration (Months)
79
Patients Per Site
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Condition or Disease Intervention/Treatment Phase
  • Drug: Mirikizumab Prefilled Syringe
  • Drug: Mirikizumab Autoinjector
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
237 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants
Actual Study Start Date :
Oct 5, 2021
Actual Primary Completion Date :
Jun 22, 2022
Actual Study Completion Date :
Jun 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirikizumab - Prefilled Syringe

Mirikizumab administered by subcutaneous injection (SC) via a prefilled syringe (PFS) at 3 different injection sites (arm, thigh, and abdomen).

Drug: Mirikizumab Prefilled Syringe
Administered SC by prefilled syringe
Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab - Autoinjector

    Mirikizumab administered by SC via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen).

    Drug: Mirikizumab Autoinjector
    Administered SC by autoinjector
    Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab [Predose up to 85 days postdose]

      PK: Cmax of Mirikizumab

    2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab [Predose up to 85 days postdose]

      PK: AUC[0-∞] of Mirikizumab

    3. PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab [Predose up to 85 days postdose]

      PK: AUC[0-tlast] of Mirikizumab

    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 non-pregnant females of childbearing or non-childbearing potential

    • Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive)

    Exclusion Criteria:

    • Must not show evidence of active or latent tuberculosis (TB)

    • Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study

    • Must not have been treated with steroids within 1 month of screening, or intend to during the study

    • Must not have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1

    • Must not be immunocompromised

    • Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1

    • Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions

    • Must not 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

    • Must not have had breast cancer within the past 10 years

    • Must not have significant allergies to humanized monoclonal antibodies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LabCorp CRU, Inc. Daytona Beach Florida United States 32117
    2 QPS Springfield Missouri United States 65802
    3 Covance Dallas Dallas Texas United States 75247

    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:
    NCT05069896
    Other Study ID Numbers:
    • 18139
    • I6T-MC-AMBX
    First Posted:
    Oct 6, 2021
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 4, 2022
    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
    Additional relevant MeSH terms:
    Mirikizumab

    Study Results

    No Results Posted as of Jul 15, 2022