A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
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
2 other identifiers
interventional
450
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 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.
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 Dec 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
December 1, 2022
CompletedStudy Start
First participant enrolled
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2023
CompletedResults Posted
Study results publicly available
March 28, 2025
CompletedMarch 28, 2025
March 1, 2025
6 months
December 1, 2022
February 13, 2025
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: Cmax of Mirikizumab
Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: AUC\[0-∞\] of Mirikizumab
Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: AUC\[0-tlast\] of Mirikizumab
Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
Study Arms (2)
Mirikizumab
EXPERIMENTALParticipants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) to abdomen or arms or thighs on Day 1.
Citrate-Free Mirikizumab
EXPERIMENTALParticipants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs 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
Clinical Pharmacology of Miami
Miami, Florida, 33014, United States
Qps-Mra, Llc
Miami, Florida, 33143, United States
Axis
Dilworth, Minnesota, 56529, United States
Labcorp Clinical Research LP
Dallas, Texas, 75247, 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
December 1, 2022
First Posted
December 9, 2022
Study Start
December 5, 2022
Primary Completion
May 25, 2023
Study Completion
May 25, 2023
Last Updated
March 28, 2025
Results First Posted
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share