Healthy
Conditions
Brief summary
The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.
Interventions
DRUGMirikizumab - IV
Administered IV
DRUGMirikizumab - SC
Administered SC
DRUGPlacebo - IV
Administered IV
DRUGPlacebo - SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination. * Are first generation Japanese or are Caucasian. * Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening. * Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.
Exclusion criteria
* Have had symptomatic herpes zoster within 3 months of screening. * Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing. * Have received live vaccine(s) within 1 month of screening or intend to during the study. * Are immunocompromised. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 85 | SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab. |
| Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration | Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo SC Participants received placebo by SC. | 2 |
| Placebo IV Participants received placebo by IV. | 10 |
| 60mg Mirikizumab IV Participants received 60mg Mirikizumab by IV. | 6 |
| 200mg Mirikizumab SC Participants received 200mg Mirikizumab by SC. | 6 |
| 200mg Mirikizumab IV Participants received 200mg Mirikizumab by IV. | 6 |
| 600mg Mirikizumab IV Participants received 600mg Mirikizumab by IV. | 9 |
| 1200mg Mirikizumab IV Participants received 1200mg Mirikizumab by IV. | 6 |
| 2400mg Mirikizumab IV Participants received 2400mg Mirikizumab by IV. | 6 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo SC | Placebo IV | 60mg Mirikizumab IV | 200mg Mirikizumab SC | 200mg Mirikizumab IV | 600mg Mirikizumab IV | 1200mg Mirikizumab IV | 2400mg Mirikizumab IV | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 2.1 | 45.7 years STANDARD_DEVIATION 10.6 | 49.3 years STANDARD_DEVIATION 9.4 | 37.3 years STANDARD_DEVIATION 8.8 | 41.7 years STANDARD_DEVIATION 16 | 46.8 years STANDARD_DEVIATION 11.9 | 37.8 years STANDARD_DEVIATION 11.9 | 45.2 years STANDARD_DEVIATION 6 | 44 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 9 Participants | 6 Participants | 3 Participants | 6 Participants | 7 Participants | 4 Participants | 5 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 25 Participants |
| Region of Enrollment United States | 2 Participants | 10 Participants | 6 Participants | 6 Participants | 6 Participants | 9 Participants | 6 Participants | 6 Participants | 51 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 5 Participants | 31 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 20 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 2 / 2 | 5 / 10 | 3 / 6 | 1 / 6 | 2 / 6 | 1 / 9 | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason
Time frame: Baseline through Day 85
Population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 60mg Mirikizumab IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 200mg Mirikizumab IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 200mg Mirikizumab SC | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 600mg Mirikizumab IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 1200mg Mirikizumab IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 2400mg Mirikizumab IV | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab
Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab.
Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
Population: All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SC | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 148 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 29 |
| Placebo IV | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 210 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 29 |
| 60mg Mirikizumab IV | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 539 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 12 |
| 200mg Mirikizumab IV | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 1970 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 24 |
| 200mg Mirikizumab SC | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 2900 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 14 |
| 600mg Mirikizumab IV | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | 5990 Microgram day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 12 |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab.
Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
Population: All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo SC | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 23.1 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 9 |
| Placebo IV | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 11.8 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 39 |
| 60mg Mirikizumab IV | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 78.8 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 13 |
| 200mg Mirikizumab IV | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 250 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 16 |
| 200mg Mirikizumab SC | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 454 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 11 |
| 600mg Mirikizumab IV | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | 985 Microgram per Milliliter (μg/mL) | Geometric Coefficient of Variation 20 |