A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector in Healthy Participants
2 other identifiers
interventional
396
1 country
6
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 autoinjector compared to mirikizumab (reference) solution given via autoinjector. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2022
Typical duration for phase_1 healthy
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 25, 2022
CompletedStudy Start
First participant enrolled
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2023
CompletedResults Posted
Study results publicly available
July 5, 2024
CompletedJuly 5, 2024
January 1, 2024
6 months
August 24, 2022
January 22, 2024
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
PK: Cmax of mirikizumab was evaluated.
Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC\[0-∞\] of Mirikizumab was evaluated.
Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab
PK: AUC\[0-tlast\] of Mirikizumab was evaluated.
Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Study Arms (2)
Mirikizumab (Reference)
EXPERIMENTAL200 milligram (mg) of mirikizumab as reference formulation \[100 mg/milliliter (mL)\], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.
Mirikizumab (Test)
EXPERIMENTAL200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630, United States
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117, United States
Axis
Dilworth, Minnesota, 56529, United States
QPS
Springfield, Missouri, 65802, United States
Labcorp Clinical Research LP
Dallas, Texas, 75247, United States
LabCorp CRU, Inc.
Madison, Wisconsin, 53704, United States
Related Publications (1)
Otani Y, Feagan BG, D'Haens GR, Escobar R, Morris NJ, Payne CD, Ugolini Lopes M, Zhang X. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025 May;42(5):2369-2384. doi: 10.1007/s12325-025-03158-y. Epub 2025 Mar 21.
PMID: 40117091DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 25, 2022
Study Start
August 31, 2022
Primary Completion
February 20, 2023
Study Completion
February 20, 2023
Last Updated
July 5, 2024
Results First Posted
July 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share