Healthy
Conditions
Brief 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. 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.
Interventions
DRUGCitrate-Free Mirikizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: * Medical history, * Physical examination, * Clinical laboratory tests, * Electrocardiogram (ECG), * 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. 2. 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 3. Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m\^2), inclusive.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: Medical conditions 4. Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation. 5. 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. 6. Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. 7. Have a diagnosis or history of malignant disease within 5 years prior to baseline. Prior/concomitant therapy 8. Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing. 9. 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. 10. Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use. 11. 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 12. 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. 13. 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. 14. Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab. Diagnostic assessments 15. Have a current infection with hepatitis C virus. 16. Have a current infection with hepatitis B virus. 17. Have a current or recent acute, active infection. 18. Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization: 1. Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both. 2. Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over. 3. Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer. 4. Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis. 19. Show evidence of active or latent tuberculosis (TB). Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | 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 | 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 | Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose. | AUC \[0 to tlast\] of Mirikizumab is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200 mg Mirikizumab (Reference) Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1. | 240 |
| 200 mg Mirikizumab (Test) 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. | 244 |
| Total | 484 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Randomized but did not receive any dose | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | 200 mg Mirikizumab (Reference) | Total | 200 mg Mirikizumab (Test) |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 11.6 | 42.5 years STANDARD_DEVIATION 12.1 | 42.4 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 111 Participants | 219 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants | 265 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 108 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 177 Participants | 351 Participants | 174 Participants |
| Region of Enrollment United States | 240 Participants | 484 Participants | 244 Participants |
| Sex: Female, Male Female | 112 Participants | 247 Participants | 135 Participants |
| Sex: Female, Male Male | 128 Participants | 237 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 0 / 244 |
| other Total, other adverse events | 55 / 240 | 48 / 244 |
| serious Total, serious adverse events | 0 / 240 | 0 / 244 |
Outcome results
Primary
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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | 12.9 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 40 |
| 200 mg Mirikizumab (Test) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | 13.5 microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 39 |
90% CI: [0.9853, 1.0956]
Primary
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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab | 220 microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 40 |
| 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 | 223 microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 41 |
90% CI: [0.9568, 1.0678]
Primary
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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab | 225 microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 41 |
| 200 mg Mirikizumab (Test) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab | 228 microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 41 |
90% CI: [0.9564, 1.0685]