A Study of Mirikizumab in Healthy Participants
A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants
2 other identifiers
interventional
240
1 country
4
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 start of the study. 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 Nov 2020
Typical duration for phase_1 healthy
4 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
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2021
CompletedResults Posted
Study results publicly available
February 20, 2024
CompletedFebruary 20, 2024
February 1, 2024
7 months
October 28, 2020
May 5, 2023
February 16, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
PK: Cmax of Mirikizumab
Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC\[0-∞\] of Mirikizumab
Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab
PK: AUC\[0-tlast\] of Mirikizumab
Predose up to 85 days postdose
Study Arms (2)
Mirikizumab - Prefilled Syringe
EXPERIMENTAL2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)
Mirikizumab - Autoinjector
EXPERIMENTAL2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)
Interventions
Administered SC by prefilled syringe
Administered SC by autoinjector
Eligibility Criteria
You may qualify if:
- Are overtly healthy males or females, as determined through medical history and physical examination
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Covance Clinical Research Inc
Daytona Beach, Florida, 32117, United States
QPS
Springfield, Missouri, 65802, United States
Covance Dallas
Dallas, Texas, 75247, United States
Covance Clinical Research Inc
Madison, Wisconsin, 53704, United States
Related Publications (1)
Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.
PMID: 40900263DERIVED
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
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2020
First Posted
October 29, 2020
Study Start
November 2, 2020
Primary Completion
May 17, 2021
Study Completion
May 17, 2021
Last Updated
February 20, 2024
Results First Posted
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share