HealthyPhase 1NCT05644353

A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

A Phase 1 study testing Mirikizumab in people with Healthy, run by Eli Lilly and Company at 6 sites in United States.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 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: 450 participants
Where: 6 sitesUnited States
Study dates: 5 Dec 2022to 25 May 2023
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
Labcorp Clinical Research LP
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117
Axis
Dilworth, Minnesota, 56529
Clinical Pharmacology of Miami
Miami, Florida, 33014
Qps-Mra, Llc
Miami, Florida, 33143

Other trials in United States

About this study

Official title: 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

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.

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
Administered SC.

Study groups in NCT05644353
Study group	Role	What they receive
Mirikizumab	Experimental	Participants 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. Receives: Drug: Mirikizumab
Citrate-Free Mirikizumab	Experimental	Participants 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. 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 in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: Cmax of Mirikizumab
Measured: 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
Measured: 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
Measured: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose

Timeline

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

5 Dec 202225 May 2023

First posted9 Dec 2022
Study start5 Dec 2022
Primary completion25 May 2023
Study completion25 May 2023

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: Single blind
Who is masked: Participant
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05644353
Sponsor's protocol ID: 17773
Other IDs: I6T-MC-AMBY
Status last verified: Mar 2025
First submitted: 1 Dec 2022
Last updated: 28 Mar 2025
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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05644353
Acronym / sponsor ID: 17773
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 5 Dec 2022 (actual)
Primary completion: 25 May 2023 (actual)
Study completion: 25 May 2023 (actual)
First posted: 9 Dec 2022 (actual)
Results: Posted 28 Mar 2025

Clinical summary

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

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.

Study design

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

Arm	Type	Receives
Mirikizumab	Experimental	Drug: MirikizumabParticipants 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	Experimental	Drug: MirikizumabParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (4 listed)

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

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: LY3074828Administered SC.	Drug	Citrate-Free Mirikizumab, Mirikizumab

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
PK: Cmax of Mirikizumab
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
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
PK: AUC[0-∞] of Mirikizumab
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
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
PK: AUC[0-tlast] of Mirikizumab

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirikizumab - Abdomen	74	72
Mirikizumab - Arm	76	74
Mirikizumab - Thigh	76	75
Citrate-Free Mirikizumab - Abdomen	75	75
Citrate-Free Mirikizumab - Arm	75	74
Citrate-Free Mirikizumab - Thigh	74	74

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation

Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (μg/mL)

Measure	Mirikizumab n = 207	Citrate-Free Mirikizumab n = 208
Value	20.9 (43)	20.9 (39)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.

Primary outcome: 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

Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose. Geometric mean (Geometric Coefficient of Variation). Unit: microgram*day per milliliter (μg*day/ mL

Measure	Mirikizumab n = 205	Citrate-Free Mirikizumab n = 208
Value	331 (39)	325 (36)

Primary outcome: 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

Measure	Mirikizumab n = 205	Citrate-Free Mirikizumab n = 208
Value	327 (39)	320 (36)

Adverse events

Time frame: Baseline Through Follow-Up (Up To 13 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirikizumab - Abdomen	0 of 74 (0%)	27 of 74 (36.5%)	0 of 74
Mirikizumab - Arm	0 of 76 (0%)	38 of 76 (50%)	0 of 76
Mirikizumab - Thigh	0 of 76 (0%)	36 of 76 (47.4%)	0 of 76
Citrate-Free Mirikizumab - Abdomen	0 of 75 (0%)	11 of 75 (14.7%)	0 of 75
Citrate-Free Mirikizumab - Arm	0 of 75 (0%)	17 of 75 (22.7%)	0 of 75
Citrate-Free Mirikizumab - Thigh	0 of 74 (0%)	17 of 74 (23%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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

6 sites 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 6 sites 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 3 inclusion and 4 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 28 Mar 2025). 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 in a Citrate-free Solution Formulation Compared to the Solution Formulation (time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose). 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 NCT05644353, 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 28 Mar 2025.