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Mirikizumab Solution (Reference) for Healthy Subjects

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

Study Summary

This trial evaluates how well a drug is tolerated & how much gets into the bloodstream when given via syringe. Adverse effects & duration of 17 wks incl. 35 day screening are also evaluated.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mirikizumab Solution (Test)Experimental Treatment1 Intervention
Mirikizumab administered by SC via a PFS at 3 different injection sites (arm, thigh, and abdomen).
Group II: Mirikizumab Solution (Reference)Experimental Treatment1 Intervention
Mirikizumab administered by subcutaneous injection (SC) via a prefilled syringe (PFS) at 3 different injection sites (arm, thigh, and abdomen).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~4790

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
2,615 Previous Clinical Trials
3,200,602 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,796 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accommodate individuals aged 25 and above?

"According to the trial's eligibility criteria, the lower limit of enrollment is 18 and no adult over 65 should apply."

Answered by AI

What safety precautions should be taken when utilizing Mirikizumab Solution (Reference)?

"There is limited safety and efficacy data for Mirikizumab Solution (Reference), warranting a rating of 1 on the scale."

Answered by AI

How widely distributed are the locales where this experiment is taking place in town?

"At present, the trial is running at 6 different medical facilities. These locations are situated in Miami, Cypress and Dallas as well as other nearby cities. It may be beneficial to opt for a centre close by so that you can reduce any travel requirements should you choose to participate."

Answered by AI

Is this research project still accommodating participants?

"Unfortunately, the clinical trial does not appear to be enrolling patients at this time according to information available on clinicaltrials.gov; it was originally posted in December 2022 and most recently updated a month ago. However, 838 other trials are currently recruiting new participants."

Answered by AI

Could I qualify to join this experiment?

"This clinical trial is recruiting 410 individuals aged between 18 and 65 years old who present as generally healthy (hs). Furthermore, participants must have a BMI between of 18.0 to 34.0 kg/m2, with only males or non-pregnant women of childbearing potential accepted for enrolment."

Answered by AI

Who else is applying?

What site did they apply to?
Altasciences Clinical Los Angeles, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
California
Recent research and studies
clinicaltrials.govStudy
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
2022. "A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05644353.
All > Fargo
~195 spots leftby Apr 2025
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