Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate 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 compared to mirikizumab (reference) solution given via autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.
Interventions
DRUGMirikizumab
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation * Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive. * are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).
Exclusion criteria
* 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 an abnormal blood pressure, pulse rate, or temperature as determined by the investigator * Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing * Are lactating or pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose | PK: Cmax of mirikizumab was evaluated. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose | PK: AUC\[0-∞\] of Mirikizumab was evaluated. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab | Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose | PK: AUC\[0-tlast\] of Mirikizumab was evaluated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200 mg Mirikizumab (Reference) Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1. | 199 |
| 200 mg Mirikizumab (Test) Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1. | 197 |
| Total | 396 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | 200 mg Mirikizumab (Reference) | Total | 200 mg Mirikizumab (Test) |
|---|---|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 13 | 40.9 years STANDARD_DEVIATION 12.6 | 41.1 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 69 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants | 327 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 59 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 150 Participants | 302 Participants | 152 Participants |
| Region of Enrollment United States | 199 Participants | 396 Participants | 197 Participants |
| Sex: Female, Male Female | 98 Participants | 202 Participants | 104 Participants |
| Sex: Female, Male Male | 101 Participants | 194 Participants | 93 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 / 63 | 0 / 69 | 0 / 67 | 0 / 66 | 0 / 66 | 0 / 65 |
| other Total, other adverse events | 11 / 63 | 12 / 69 | 13 / 67 | 7 / 66 | 11 / 66 | 12 / 65 |
| serious Total, serious adverse events | 0 / 63 | 0 / 69 | 0 / 67 | 0 / 66 | 0 / 66 | 0 / 65 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
PK: Cmax of mirikizumab was evaluated.
Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Population: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 13.0 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 42 |
| 200 mg Mirikizumab (Test) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 12.9 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 40 |
90% CI: [0.929, 1.05]
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC\[0-∞\] of Mirikizumab was evaluated.
Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Population: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
| 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 | 229 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 43 |
| 200 mg Mirikizumab (Test) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab | 232 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 42 |
90% CI: [0.948, 1.08]
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab
PK: AUC\[0-tlast\] of Mirikizumab was evaluated.
Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Population: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 200 mg Mirikizumab (Reference) | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab | 225 μg*day/mL | Geometric Coefficient of Variation 42 |
| 200 mg Mirikizumab (Test) | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab | 231 μg*day/mL | Geometric Coefficient of Variation 41 |
90% CI: [0.96, 1.09]