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 pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. 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 in a Citrate-free Solution Formulation Compared to the Solution Formulation | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose | PK: Cmax of Mirikizumab |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose | 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 in a Citrate-free Solution Formulation Compared to the Solution Formulation | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose | PK: AUC\[0-tlast\] of Mirikizumab |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirikizumab - Abdomen Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen on Day 1. | 74 |
| Mirikizumab - Arm Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1. | 76 |
| Mirikizumab - Thigh Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1. | 76 |
| Citrate-Free Mirikizumab - Abdomen Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to the abdomen on Day 1. | 75 |
| Citrate-Free Mirikizumab - Arm Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1. | 75 |
| Citrate-Free Mirikizumab - Thigh Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1. | 74 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Mirikizumab - Abdomen | Total | Citrate-Free Mirikizumab - Thigh | Citrate-Free Mirikizumab - Arm | Citrate-Free Mirikizumab - Abdomen | Mirikizumab - Thigh | Mirikizumab - Arm |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.2 years STANDARD_DEVIATION 12.9 | 40.9 years STANDARD_DEVIATION 12.6 | 40.8 years STANDARD_DEVIATION 12.5 | 41.4 years STANDARD_DEVIATION 12.5 | 40.3 years STANDARD_DEVIATION 12.5 | 41.5 years STANDARD_DEVIATION 11.9 | 41.9 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 271 Participants | 44 Participants | 44 Participants | 45 Participants | 48 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 178 Participants | 30 Participants | 31 Participants | 30 Participants | 28 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 10 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 67 Participants | 13 Participants | 12 Participants | 9 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 10 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 56 Participants | 353 Participants | 53 Participants | 56 Participants | 64 Participants | 62 Participants | 62 Participants |
| Region of Enrollment United States | 74 Participants | 450 Participants | 74 Participants | 75 Participants | 75 Participants | 76 Participants | 76 Participants |
| Sex: Female, Male Female | 38 Participants | 238 Participants | 35 Participants | 38 Participants | 36 Participants | 41 Participants | 50 Participants |
| Sex: Female, Male Male | 36 Participants | 212 Participants | 39 Participants | 37 Participants | 39 Participants | 35 Participants | 26 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 / 74 | 0 / 76 | 0 / 76 | 0 / 75 | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 27 / 74 | 38 / 76 | 36 / 76 | 11 / 75 | 17 / 75 | 17 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 76 | 0 / 76 | 0 / 75 | 0 / 75 | 0 / 74 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: Cmax of Mirikizumab
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 20.9 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 43 |
| Citrate-Free Mirikizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 20.9 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 39 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: AUC\[0-tlast\] of Mirikizumab
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 327 microgram*day per milliliter (μg*day/ mL | Geometric Coefficient of Variation 39 |
| Citrate-Free Mirikizumab | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 320 microgram*day per milliliter (μg*day/ mL | Geometric Coefficient of Variation 36 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
PK: AUC\[0-∞\] of Mirikizumab
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
Population: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 331 microgram*day per milliliter (μg*day/ mL | Geometric Coefficient of Variation 39 |
| Citrate-Free Mirikizumab | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | 325 microgram*day per milliliter (μg*day/ mL | Geometric Coefficient of Variation 36 |