HealthyPhase 1NCT06475729

A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

A Phase 1 study testing Citrate-Free 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.

Official record

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Trial summary

The purpose of this study is to evaluate the 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 autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector. 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?: Citrate-Free Mirikizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 498 participants
Where: 6 sitesUnited States
Study dates: 24 Jun 2024to 27 Dec 2024
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

Type of participant and disease characteristics
Overtly healthy males and females as determined by medical evaluation including:
Medical history,
Physical examination,
Clinical laboratory tests,
Electrocardiogram (ECG),

Show all 14Show fewer

Vital signs
Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Have clinical laboratory test results:
Within normal reference range for the population, or
Within normal reference range for the investigative site, or
Results with acceptable deviations that are judged to be not clinically significant by the investigator.
Weight
Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m^2), inclusive.

Who cannot join

Participants are excluded from the study if any of the following criteria apply:
Medical conditions
Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
Have a diagnosis or history of malignant disease within 5 years prior to baseline.

Show all 29Show fewer

Prior/concomitant therapy
Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing.
Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use.
Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization.
Prior/concurrent clinical study experience
Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.
Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.
Diagnostic assessments
Have a current infection with hepatitis C virus.
Have a current infection with hepatitis B virus.
Have a current or recent acute, active infection.
Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:
Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both.
Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer.
Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis.
Show evidence of active or latent tuberculosis (TB).
Other exclusion criteria
Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions.
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

CenExel ACT
Anaheim, California, 92801
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
Clinical Pharmacology of Miami
Miami, Florida, 33014-3616
QPS Missouri
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants

Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

Conditions: Healthy
Being tested: Citrate-Free Mirikizumab

What participants receive

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

Citrate-Free MirikizumabDrug
Also called LY3074828
Administered SC

Study groups in NCT06475729
Study group	Role	What they receive
200 mg Mirikizumab (Test)	Experimental	Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. Receives: Drug: Citrate-Free Mirikizumab
200 mg Mirikizumab (Reference)	Experimental	Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. Receives: Drug: Citrate-Free Mirikizumab

What is being measured

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

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Cmax of Mirikizumab is reported.
Measured: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
AUC [0-∞] of Mirikizumab is reported.
Measured: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
AUC [0 to tlast] of Mirikizumab is reported.
Measured: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Timeline

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

24 Jun 202427 Dec 2024

First posted26 Jun 2024
Study start24 Jun 2024
Primary completion27 Dec 2024
Study completion27 Dec 2024

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 498 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06475729
Sponsor's protocol ID: 18852
Other IDs: I6T-MC-AMCB
Status last verified: Dec 2025
First submitted: 21 Jun 2024
Last updated: 30 Dec 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, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2026 Jan;43(1):377-389. doi: 10.1007/s12325-025-03422-1. Epub 2025 Nov 28.
PubMed 41313544

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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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants
ClinicalTrials.gov ID: NCT06475729
Acronym / sponsor ID: 18852
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 498 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 24 Jun 2024 (actual)
Primary completion: 27 Dec 2024 (actual)
Study completion: 27 Dec 2024 (actual)
First posted: 26 Jun 2024 (actual)
Results: Posted 30 Dec 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 enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
200 mg Mirikizumab (Test)	Experimental	Drug: Citrate-Free MirikizumabParticipants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
200 mg Mirikizumab (Reference)	Experimental	Drug: Citrate-Free MirikizumabParticipants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.

Who may qualify

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

Key inclusion criteria (14 listed)

Type of participant and disease characteristics
Overtly healthy males and females as determined by medical evaluation including:
Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Have clinical laboratory test results:
Weight

Key exclusion criteria (29 listed)

Medical conditions
Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
Have a diagnosis or history of malignant disease within 5 years prior to baseline.

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
Citrate-Free MirikizumabAlso: LY3074828Administered SC	Drug	200 mg Mirikizumab (Reference), 200 mg Mirikizumab (Test)

Primary outcome

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
Cmax of Mirikizumab is reported.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
AUC [0-∞] of Mirikizumab is reported.
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
AUC [0 to tlast] of Mirikizumab is reported.

Results and safety

Results posted to the registry on 30 Dec 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
200 mg Mirikizumab (Reference)	249	237
200 mg Mirikizumab (Test)	249	241

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

Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: microgram per milliliter (ug/mL)

Measure	200 mg Mirikizumab (Reference) n = 238	200 mg Mirikizumab (Test) n = 243
Value	12.9 (40)	13.5 (39)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 1.039 (90% CI 0.9853 to 1.0956)

Population analysed: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

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

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

Measure	200 mg Mirikizumab (Reference) n = 238	200 mg Mirikizumab (Test) n = 243
Value	225 (41)	228 (41)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 1.011 (90% CI 0.9564 to 1.0685)

Population analysed: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab

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

Measure	200 mg Mirikizumab (Reference) n = 238	200 mg Mirikizumab (Test) n = 241
Value	220 (40)	223 (41)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 1.011 (90% CI 0.9568 to 1.0678)

Population analysed: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

Adverse events

Time frame: Baseline up to Day 74. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 mg Mirikizumab (Reference)	0 of 240 (0%)	55 of 240 (22.9%)	0 of 240
200 mg Mirikizumab (Test)	0 of 244 (0%)	48 of 244 (19.7%)	0 of 244

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41313544Otani Y, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2026 Jan;43(1):377-389. doi: 10.1007/s12325-025-03422-1. Epub 2025 Nov 28.
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 Citrate-Free 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 14 inclusion and 29 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 30 Dec 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 30 Dec 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 Observed Drug Concentration (Cmax) of Mirikizumab (time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-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 NCT06475729, 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 30 Dec 2025.