HealthyPhase 1NCT04548219

A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

A Phase 1 study testing Mirikizumab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Mirikizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 11 Sep 2020to 11 Jan 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy males or females, as determined through medical history and physical examination

Who cannot join

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

Show all 11Show fewer

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
Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions

Trial locations and contacts

1 site in 1 country.

United States1 site

QPS
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects

Conditions: Healthy
Being tested: Mirikizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MirikizumabDrug
Also called LY3074828
Reference and test formulations of mirikizumab administered as a SC injection.

Study groups in NCT04548219
Study group	Role	What they receive
Mirikizumab (Reference)	Experimental	200 milligram (mg) of mirikizumab as reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1. Receives: Drug: Mirikizumab
Mirikizumab (Test)	Experimental	200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1. Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
PK: Cmax of mirikizumab was evaluated.
Measured: 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-inf]) of Mirikizumab
PK: AUC(0-inf) of mirikizumab was evaluated.
Measured: 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 t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab
PK: (AUC[0-tlast]) of mirikizumab was evaluated.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202011 Jan 2021

First posted14 Sep 2020
Study start11 Sep 2020
Primary completion11 Jan 2021
Study completion11 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04548219
Sponsor's protocol ID: 17667
Other IDs: I6T-MC-AMBV
Status last verified: May 2023
First submitted: 10 Sep 2020
Last updated: 25 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40117091

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects
ClinicalTrials.gov ID: NCT04548219
Acronym / sponsor ID: 17667
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 11 Sep 2020 (actual)
Primary completion: 11 Jan 2021 (actual)
Study completion: 11 Jan 2021 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 25 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Mirikizumab (Reference)	Experimental	Drug: Mirikizumab200 milligram (mg) of mirikizumab as reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.
Mirikizumab (Test)	Experimental	Drug: Mirikizumab200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Are overtly healthy males or females, as determined through medical history and physical examination

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MirikizumabAlso: LY3074828Reference and test formulations of mirikizumab administered as a SC injection.	Drug	Mirikizumab (Reference), Mirikizumab (Test)

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
Time frame: 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: Cmax of mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab
Time frame: 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: AUC(0-inf) of mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab
Time frame: 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: (AUC[0-tlast]) of mirikizumab was evaluated.

Results and safety

Results posted to the registry on 25 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
200 Milligram (mg) Mirikizumab (Reference): Arm	10	10
200 mg Mirikizumab (Reference): Thigh	10	10
200 mg Mirikizumab (Reference): Abdomen	10	10
200 mg Mirikizumab (Test): Arm	10	10
200 mg Mirikizumab (Test): Thigh	10	10
200 mg Mirikizumab (Test): Abdomen	10	10

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (ug/mL)

Measure	200 mg Mirikizumab (Reference) n = 30	200 mg Mirikizumab (Test) n = 30
Value	12.7 (48)	11.6 (45)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 0.907 (90% CI 0.775 to 1.06)

Population analysed: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ug*day/mL

Measure	200 mg Mirikizumab (Reference) n = 30	200 mg Mirikizumab (Test) n = 30
Value	229 (56)	209 (45)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 0.915 (90% CI 0.761 to 1.10)

Population analysed: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to t, Where t is the Last Timepoint With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ug*day/mL

Measure	200 mg Mirikizumab (Reference) n = 30	200 mg Mirikizumab (Test) n = 30
Value	225 (56)	206 (46)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 0.915 (90% CI 0.760 to 1.10)

Population analysed: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

Adverse events

Time frame: Up To 85 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 mg Mirikizumab (Reference): Arm	0 of 10 (0%)	0 of 10 (0%)	0 of 10
200 mg Mirikizumab (Reference): Thigh	0 of 10 (0%)	2 of 10 (20%)	0 of 10
200 mg Mirikizumab (Reference): Abdomen	0 of 10 (0%)	1 of 10 (10%)	0 of 10
200 mg Mirikizumab (Test): Arm	0 of 10 (0%)	0 of 10 (0%)	0 of 10
200 mg Mirikizumab (Test): Thigh	0 of 10 (0%)	0 of 10 (0%)	0 of 10
200 mg Mirikizumab (Test): Abdomen	0 of 10 (0%)	3 of 10 (30%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40117091Otani 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirikizumab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.