Healthy
Conditions
Brief summary
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
Interventions
BIOLOGICALMirikizumab Test
Administered SC
BIOLOGICALMirikizumab Reference
Administered SC
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
* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive * Have medical test results that are acceptable for the study * Must be willing to make oneself available for the whole study and be willing to follow study procedures
Exclusion criteria
* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study * Have known allergies to compounds or drugs similar to Mirikizumab * Have previously participated or withdrawn from this study * Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose | PK: Maximum Observed Concentration (Cmax) of Mirikizumab |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirikizumab Reference 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants. | 17 |
| Mirikizumab Test SC 2 250 mg mirikizumab test formulation given as two injections given SC in healthy participants | 16 |
| Mirikizumab Test SC 1 250 mg mirikizumab test formulation given as a single injection SC in healthy participants | 17 |
| Mirikizumab Test Intravenous (IV) 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants | 17 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Mirikizumab Test Intravenous (IV) | Total | Mirikizumab Reference | Mirikizumab Test SC 2 | Mirikizumab Test SC 1 |
|---|---|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 14.9 | 45.4 years STANDARD_DEVIATION 14.5 | 44.7 years STANDARD_DEVIATION 13.3 | 40.7 years STANDARD_DEVIATION 18 | 52.1 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 65 Participants | 17 Participants | 16 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 63 Participants | 17 Participants | 13 Participants | 17 Participants |
| Region of Enrollment United Kingdom | 17 Participants | 67 Participants | 17 Participants | 16 Participants | 17 Participants |
| Sex: Female, Male Female | 8 Participants | 28 Participants | 6 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 39 Participants | 11 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 17 / 17 | 15 / 16 | 17 / 17 | 15 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Population: All participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab Reference | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | 215 Microgram* Day/Milliliter(µg*day/mL) | Geometric Coefficient of Variation 31 |
| Mirikizumab Test SC 2 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | 214 Microgram* Day/Milliliter(µg*day/mL) | Geometric Coefficient of Variation 55 |
| Mirikizumab Test SC 1 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | 293 Microgram* Day/Milliliter(µg*day/mL) | Geometric Coefficient of Variation 36 |
| Mirikizumab Test Intravenous (IV) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab | 695 Microgram* Day/Milliliter(µg*day/mL) | Geometric Coefficient of Variation 22 |
90% CI: [0.807, 1.23]
90% CI: [0.591, 0.898]
90% CI: [0.343, 0.518]
90% CI: [0.249, 0.379]
Secondary
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Population: All participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab Reference | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 11.4 Microgram/Milliliter (µg/mL) | Geometric Coefficient of Variation 34 |
| Mirikizumab Test SC 2 | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 11.2 Microgram/Milliliter (µg/mL) | Geometric Coefficient of Variation 51 |
| Mirikizumab Test SC 1 | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 14.9 Microgram/Milliliter (µg/mL) | Geometric Coefficient of Variation 32 |
| Mirikizumab Test Intravenous (IV) | PK: Maximum Observed Concentration (Cmax) of Mirikizumab | 90.0 Microgram/Milliliter (µg/mL) | Geometric Coefficient of Variation 14 |
90% CI: [0.81, 1.2]
90% CI: [0.619, 0.916]
Secondary
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Population: All participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mirikizumab Reference | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | 73.12 Hour (h) |
| Mirikizumab Test SC 2 | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | 73.41 Hour (h) |
| Mirikizumab Test SC 1 | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | 73.25 Hour (h) |
| Mirikizumab Test Intravenous (IV) | PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab | 2.00 Hour (h) |
90% CI: [-0.1, 48.4]
90% CI: [-0.25, 23.97]