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A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04548219
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
Jan 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirikizumab (Reference)

Reference formulation of mirikizumab administered as a subcutaneous (SC) injection.

Drug: Mirikizumab
Administered SC.
Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab (Test)

    Test formulation of mirikizumab administered as a SC injection.

    Drug: Mirikizumab
    Administered SC.
    Other Names:
  • LY3074828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab [Predose on Day 1 through Day 85]

      PK: Cmax of Mirikizumab

    2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Mirikizumab [Predose on Day 1 through Day 85]

      PK: AUC(0-inf) of Mirikizumab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Are overtly healthy males or females, as determined through medical history and physical examination
    Exclusion Criteria:

    • Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)

    • 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 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 QPS Springfield Missouri United States 65802

    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:
    NCT04548219
    Other Study ID Numbers:
    • 17667
    • I6T-MC-AMBV
    First Posted:
    Sep 14, 2020
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Jan 1, 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
    Additional relevant MeSH terms:
    Mirikizumab

    Study Results

    No Results Posted as of Jan 29, 2021