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A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05644353
Collaborator
(none)
410
Enrollment
6
Locations
2
Arms
5.6
Anticipated Duration (Months)
68.3
Patients Per Site
12.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
410 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using Investigational 1-mL and 2-mL Prefilled Syringes and Mirikizumab Test Solution Formulation Using Investigational 1-mL and 2-mL Prefilled Syringes in Healthy Participants
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
May 23, 2023
Anticipated Study Completion Date :
May 23, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirikizumab Solution (Reference)

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

Drug: Mirikizumab
Administered SC.
Other Names:
  • LY3074828

    		•
    Experimental: Mirikizumab Solution (Test)

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

    Drug: Mirikizumab
    Administered SC.
    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:

    • Participants who are overtly healthy as determined by medical evaluation

    • Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.

    • Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).

    Exclusion Criteria:

    • Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy

    • Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator

    • Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing

    • Are lactating or pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altasciences Clinical Los Angeles, Inc Cypress California United States 90630
    2 LabCorp CRU, Inc. Daytona Beach Florida United States 32117
    3 Clinical Pharmacology of Miami Miami Florida United States 33014
    4 Qps-Mra, Llc Miami Florida United States 33143
    5 Axis Dilworth Minnesota United States 56529
    6 Labcorp Clinical Research LP 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:
    NCT05644353
    Other Study ID Numbers:
    • 17773
    • I6T-MC-AMBY
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 28, 2022
    Last Verified:
    Dec 16, 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 Dec 28, 2022