HealthyPhase 1NCT05515601

A Bioequivalence Study of Mirikizumab (LY3074828) 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 autoinjector 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?: Mirikizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 396 participants
Where: 6 sitesUnited States
Study dates: 31 Aug 2022to 20 Feb 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
LabCorp CRU, Inc.
Madison, Wisconsin, 53704
QPS
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector 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
Administered SC.

Study groups in NCT05515601
Study group	Role	What they receive
Mirikizumab (Reference)	Experimental	200 milligram (mg) of mirikizumab as reference formulation [100 mg/milliliter (mL)], 2 × 1-mL autoinjector 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 autoinjector 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-∞]) of Mirikizumab
PK: AUC[0-∞] 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 the Last 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.

31 Aug 202220 Feb 2023

First posted25 Aug 2022
Study start31 Aug 2022
Primary completion20 Feb 2023
Study completion20 Feb 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: 396 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05515601
Sponsor's protocol ID: 17327
Other IDs: I6T-MC-AMBT
Status last verified: Jan 2024
First submitted: 24 Aug 2022
Last updated: 5 Jul 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 5 Jul 2024. 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 an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector in Healthy Participants
ClinicalTrials.gov ID: NCT05515601
Acronym / sponsor ID: 17327
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 396 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 31 Aug 2022 (actual)
Primary completion: 20 Feb 2023 (actual)
Study completion: 20 Feb 2023 (actual)
First posted: 25 Aug 2022 (actual)
Results: Posted 5 Jul 2024

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 (Reference)	Experimental	Drug: Mirikizumab200 milligram (mg) of mirikizumab as reference formulation [100 mg/milliliter (mL)], 2 × 1-mL autoinjector 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 autoinjector administered as a SC injection into the 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 (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
MirikizumabAdministered SC.	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-∞]) 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-∞] of Mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last 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 5 Jul 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): Abdomen	63	62
200 mg Mirikizumab (Reference): Arm	69	66
200 mg Mirikizumab (Reference): Thigh	67	65
200 mg Mirikizumab (Test): Abdomen	66	65
200 mg Mirikizumab (Test): Arm	66	64
200 mg Mirikizumab (Test): Thigh	65	64

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 (μg/mL)

Measure	200 mg Mirikizumab (Reference) n = 196	200 mg Mirikizumab (Test) n = 192
Value	13.0 (42)	12.9 (40)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 0.986 (90% CI 0.929 to 1.05)

Population analysed: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.

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

Measure	200 mg Mirikizumab (Reference) n = 195	200 mg Mirikizumab (Test) n = 192
Value	229 (43)	232 (42)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 1.01 (90% CI 0.948 to 1.08)

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last 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: μg*day/mL

Measure	200 mg Mirikizumab (Reference) n = 193	200 mg Mirikizumab (Test) n = 187
Value	225 (42)	231 (41)

200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test): Ratio of Geometric least squares mean: 1.02 (90% CI 0.960 to 1.09)

Adverse events

Time frame: Baseline 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): Abdomen	0 of 63 (0%)	11 of 63 (17.5%)	0 of 63
200 mg Mirikizumab (Reference): Arm	0 of 69 (0%)	12 of 69 (17.4%)	0 of 69
200 mg Mirikizumab (Reference): Thigh	0 of 67 (0%)	13 of 67 (19.4%)	0 of 67
200 mg Mirikizumab (Test): Abdomen	0 of 66 (0%)	7 of 66 (10.6%)	0 of 66
200 mg Mirikizumab (Test): Arm	0 of 66 (0%)	11 of 66 (16.7%)	0 of 66
200 mg Mirikizumab (Test): Thigh	0 of 65 (0%)	12 of 65 (18.5%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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

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 5 Jul 2024. 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 5 Jul 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 NCT05515601, 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 5 Jul 2024.