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A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 85 days postdose
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two ways to give the medication mirikizumab: using a manual prefilled syringe or an autoinjector. It aims to see how much of the drug enters the bloodstream and how quickly it leaves the body. The study will also check for any side effects and how well people tolerate the medication. Mirikizumab has shown effectiveness and was well tolerated in previous studies for patients with moderate to severe ulcerative colitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 85 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 85 days postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab

Side effects data

From 2021 Phase 1 trial • 240 Patients • NCT04607733
10%
Injection site reaction
7%
Headache
5%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
AI (Test) Thigh
AI (Test) Abdomen
AI (Test) Arm
PFS (Reference) Abdomen
PFS (Reference) Thigh
PFS (Reference) Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mirikizumab - Prefilled SyringeExperimental Treatment1 Intervention
Mirikizumab administered by subcutaneous injection (SC) via a prefilled syringe (PFS) at 3 different injection sites (arm, thigh, and abdomen).
Group II: Mirikizumab - AutoinjectorExperimental Treatment1 Intervention
Mirikizumab administered by SC via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab Prefilled Syringe
2020
Completed Phase 1
~480
Mirikizumab Autoinjector
2020
Completed Phase 1
~480

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,516 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
427,931 Total Patients Enrolled
~57 spots leftby Dec 2025
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