Healthy
Conditions
Brief 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. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. 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.
Interventions
Administered SC by prefilled syringe
Administered SC by autoinjector
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined through medical history and physical examination
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 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 | 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 | Predose up to 85 days postdose | PK: AUC\[0-tlast\] of Mirikizumab |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AI (Test) AI (Test):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). | 120 |
| PFS (Reference) PFS (Reference):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | AI (Test) | Total | PFS (Reference) |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 12 | 41.7 years STANDARD_DEVIATION 12.2 | 40.1 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 41 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 199 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 49 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 97 Participants | 180 Participants | 83 Participants |
| Region of Enrollment United States | 120 Participants | 240 Participants | 120 Participants |
| Sex: Female, Male Female | 68 Participants | 139 Participants | 71 Participants |
| Sex: Female, Male Male | 52 Participants | 101 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 39 | 0 / 41 | 0 / 40 | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 7 / 40 | 6 / 39 | 8 / 41 | 6 / 40 | 5 / 41 | 6 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 | 0 / 41 | 0 / 40 | 0 / 41 | 0 / 39 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
PK: Cmax of Mirikizumab
Time frame: Predose up to 85 days postdose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PFS (Reference) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 14.3 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 44 |
| AI (Test) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 15.2 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 40 |
Primary
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
Time frame: Predose up to 85 days postdose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PFS (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab | 244 micrograms*day/milliliter (µg*day/mL) | Geometric Coefficient of Variation 44 |
| AI (Test) | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab | 257 micrograms*day/milliliter (µg*day/mL) | Geometric Coefficient of Variation 39 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC\[0-∞\] of Mirikizumab
Time frame: Predose up to 85 days postdose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PFS (Reference) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab | 246 micrograms*day/milliliter (µg*day/mL) | Geometric Coefficient of Variation 44 |
| AI (Test) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab | 262 micrograms*day/milliliter (µg*day/mL) | Geometric Coefficient of Variation 39 |