A Phase 1 interventional study of Citrate-Free Mirikizumab in Healthy, sponsored by Eli Lilly and Company. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
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.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
Have a diagnosis or history of malignant disease within 5 years prior to baseline.
Prior/concomitant therapy
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
Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.
Diagnostic assessments
Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:
Show evidence of active or latent tuberculosis (TB).
Other exclusion criteria
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.
Drug: Citrate-Free Mirikizumab
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.
Drug: Citrate-Free Mirikizumab
Administered SC
Also known as: LY3074828
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Cmax of Mirikizumab is reported.
Time frame: 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.
Time frame: 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.
Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
| Milestone | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) |
|---|---|---|
| Started | 249 | 249 |
| All participants who were exposed to study intervention (safety population) | 240 | 244 |
| Completed | 237 | 241 |
| Not completed | 12 | 8 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Randomized but did not receive any dose | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Physician decision | 5 | 2 |
| Withdrew: Adverse event | 1 | 1 |
Cmax of Mirikizumab is reported.
| microgram per milliliter (ug/mL) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | 12.9 ± 40 | 13.5 ± 39 |
AUC \[0-∞\] of Mirikizumab is reported.
| microgram*day per milliliter (ug*day/mL) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab | 225 ± 41 | 228 ± 41 |
AUC \[0 to tlast\] of Mirikizumab is reported.
| microgram*day per milliliter (ug*day/mL) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab | 220 ± 40 | 223 ± 41 |
Collected over Baseline up to Day 74. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | 0/240 (0%) | 0/240 (0%) | 55/240 (22.9%) |
| 200 mg Mirikizumab (Test) | 0/244 (0%) | 0/244 (0%) | 48/244 (19.7%) |
| Event | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) |
|---|---|---|
| HeadacheNervous system disorders | 9/240 | 12/244 |
| Injection site reactionGeneral disorders | 4/240 | 5/244 |
| Upper respiratory tract infectionInfections and infestations | 4/240 | 1/244 |
| Back painMusculoskeletal and connective tissue disorders | 4/240 | 0/244 |
| NauseaGastrointestinal disorders | 3/240 | 2/244 |
| PharyngitisInfections and infestations | 3/240 | 2/244 |
| HyperkalaemiaMetabolism and nutrition disorders | 3/240 | 2/244 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 3/240 | 0/244 |
| DiarrhoeaGastrointestinal disorders | 2/240 | 2/244 |
| VomitingGastrointestinal disorders | 2/240 | 0/244 |
All participants who were exposed to study intervention (Safety Population).
| Age, Continuous(years) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|
| Mean | 42.7 ± 11.6 | 42.4 ± 12.5 | 42.5 ± 12.1 |
| Sex: Female, Male(Participants) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|
| Female | 112 | 135 | 247 |
| Male | 128 | 109 | 237 |
| Ethnicity (NIH/OMB)(Participants) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|
| Hispanic or Latino | 111 | 108 | 219 |
| Not Hispanic or Latino | 129 | 136 | 265 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 8 | 10 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 52 | 56 | 108 |
| White | 177 | 174 | 351 |
| More than one race | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 200 mg Mirikizumab (Reference) | 200 mg Mirikizumab (Test) | Total |
|---|---|---|---|
| United States | 240 | 244 | 484 |
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