HealthyPhase 1NCT07446101
A Study of Mirikizumab Solution (LY3074828) in Healthy Participants
A Phase 1 study testing Mirikizumab in people with Healthy, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. 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
- 5 sitesUnited States
- Study dates
- 24 Mar 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 by medical evaluation including:
- medical history
- physical examination
- clinical laboratory tests
- ECG, and
- vital signs.
- Have clinical laboratory test results at screening and Day -1 within normal reference range.
- Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive.
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 significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- Are immunocompromised.
- 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 within 3 months or 5 half-lives, whichever is longer, prior to dosing.
Show all 11Show fewer
- Have previously received mirikizumab.
- Have an abnormality in the 12-lead electrocardiogram (ECG).
- Have clinically significant abnormalities in blood pressure, pulse rate, or body temperature.
- Have a current or recent acute, active infection.
- Have active tuberculosis (TB), or any history of active TB.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Archie Bowie
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700
Kathleen Doisy
- Recruiting
Axis Clinicals LLC
Dilworth, Minnesota, 56529
218-284-2947, Option 2
John Mickelson
- Recruiting
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
866-429-3700
Kimberly Cruz
- Recruiting
Worldwide Clinical Trials, Inc.
San Antonio, Texas, 78217
210-635-1500
Alan Hand
About this study
Official title: An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.
- 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 group | Role | What they receive |
|---|---|---|
| Mirikizumab (Test Arm 1) | Experimental | Mirikizumab administered subcutaneously (SC) Receives: Drug: Mirikizumab |
| Mirikizumab (Test Arm 2) | Experimental | Mirikizumab administered SC Receives: Drug: Mirikizumab |
| Mirikizumab (Reference Arm) | Experimental | Mirikizumab administered SC 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 LY3074828
Measured: Day 1 through Day 71
PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828
Measured: Day 1 through Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start24 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446101
- Sponsor's protocol ID
- 27403
- Other IDs
- I6T-MC-AMCG
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Two-Stage Bioequivalence Study of Subcutaneous Injections of Mirikizumab Solution in Healthy Participants
- ClinicalTrials.gov ID
- NCT07446101
- Acronym / sponsor ID
- 27403
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab (Test Arm 1) | Experimental | Drug: MirikizumabMirikizumab administered subcutaneously (SC) |
| Mirikizumab (Test Arm 2) | Experimental | Drug: MirikizumabMirikizumab administered SC |
| Mirikizumab (Reference Arm) | Experimental | Drug: MirikizumabMirikizumab administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are overtly healthy males or females as determined by medical evaluation including:
- Have clinical laboratory test results at screening and Day -1 within normal reference range.
- Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive.
Key exclusion criteria (11 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 significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
- Are immunocompromised.
- Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
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 | Mirikizumab (Reference Arm), Mirikizumab (Test Arm 1), Mirikizumab (Test Arm 2) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
Time frame: Day 1 through Day 71
PK: Area Under the Concentration Versus Time Curve (AUC)(0-∞) of LY3074828
Time frame: Day 1 through Day 71
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 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 5 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 8 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 (time frame: Day 1 through Day 71). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.