HealthyPhase 1NCT04607733

A Study of Mirikizumab in Healthy Participants

A Phase 1 study testing Mirikizumab Prefilled Syringe and Mirikizumab Autoinjector in people with Healthy, run by Eli Lilly and Company at 4 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 main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or 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 Prefilled Syringe and Mirikizumab Autoinjector
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 4 sitesUnited States
Study dates: 2 Nov 2020to 17 May 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 65 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 10Show 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Covance Dallas
Dallas, Texas, 75247
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
Covance Clinical Research Inc
Madison, Wisconsin, 53704
QPS
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.

Conditions: Healthy
Being tested: Mirikizumab Prefilled Syringe, Mirikizumab Autoinjector

What participants receive

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

Mirikizumab Prefilled SyringeDrug
Also called LY3074828
Administered SC by prefilled syringe
Mirikizumab AutoinjectorDrug
Also called LY3074828
Administered SC by autoinjector

Study groups in NCT04607733
Study group	Role	What they receive
Mirikizumab - Prefilled Syringe	Experimental	2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS) Receives: Drug: Mirikizumab Prefilled Syringe
Mirikizumab - Autoinjector	Experimental	2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI) Receives: Drug: Mirikizumab Autoinjector

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
Measured: Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC[0-∞] of Mirikizumab
Measured: Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab
PK: AUC[0-tlast] of Mirikizumab
Measured: Predose up to 85 days postdose

Timeline

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

2 Nov 202017 May 2021

First posted29 Oct 2020
Study start2 Nov 2020
Primary completion17 May 2021
Study completion17 May 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: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04607733
Sponsor's protocol ID: 17820
Other IDs: I6T-MC-AMBW
Status last verified: Feb 2024
First submitted: 28 Oct 2020
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.
PubMed 40900263

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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants
ClinicalTrials.gov ID: NCT04607733
Acronym / sponsor ID: 17820
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 2 Nov 2020 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 29 Oct 2020 (actual)
Results: Posted 20 Feb 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 28 days prior to the start of the study. 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: None (open label)
Number of arms: 2

Arm	Type	Receives
Mirikizumab - Prefilled Syringe	Experimental	Drug: Mirikizumab Prefilled Syringe2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)
Mirikizumab - Autoinjector	Experimental	Drug: Mirikizumab Autoinjector2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)

Who may qualify

Ages: 18 to 65 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 (10 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
Mirikizumab Prefilled SyringeAlso: LY3074828Administered SC by prefilled syringe	Drug	Mirikizumab - Prefilled Syringe
Mirikizumab AutoinjectorAlso: LY3074828Administered SC by autoinjector	Drug	Mirikizumab - Autoinjector

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
Time frame: Predose up to 85 days postdose
PK: Cmax of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
Time frame: Predose up to 85 days postdose
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
Time frame: Predose up to 85 days postdose
PK: AUC[0-tlast] of Mirikizumab

Results and safety

Results posted to the registry on 20 Feb 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
AI (Test) Abdomen	40	39
AI (Test) Arm	39	39
AI (Test) Thigh	41	41
PFS (Reference) Abdomen	40	39
PFS (Reference) Arm	41	39
PFS (Reference) Thigh	39	39

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

Time frame: Predose up to 85 days postdose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: micrograms/milliliter (µg/mL)

Measure	PFS (Reference) n = 120	AI (Test) n = 120
Value	14.3 (44)	15.2 (40)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.

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

Time frame: Predose up to 85 days postdose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms*day/milliliter (µg*day/mL)

Measure	PFS (Reference) n = 120	AI (Test) n = 120
Value	246 (44)	262 (39)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.

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

Time frame: Predose up to 85 days postdose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms*day/milliliter (µg*day/mL)

Measure	PFS (Reference) n = 116	AI (Test) n = 119
Value	244 (44)	257 (39)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.

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
AI (Test) Abdomen	0 of 40 (0%)	7 of 40 (17.5%)	0 of 40
AI (Test) Arm	0 of 39 (0%)	6 of 39 (15.4%)	0 of 39
AI (Test) Thigh	0 of 41 (0%)	8 of 41 (19.5%)	0 of 41
PFS (Reference) Abdomen	0 of 40 (0%)	6 of 40 (15%)	0 of 40
PFS (Reference) Arm	0 of 41 (0%)	5 of 41 (12.2%)	0 of 41
PFS (Reference) Thigh	0 of 39 (0%)	6 of 39 (15.4%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40900263Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.
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

4 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 Prefilled Syringe and Mirikizumab Autoinjector in people with Healthy, run by Eli Lilly and Company at 4 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 1 inclusion and 10 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 20 Feb 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 up to 85 days 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 NCT04607733, 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 20 Feb 2024.