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 enrolment. 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 non-pregnant females of childbearing or non-childbearing potential * Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive)
Exclusion criteria
* 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 have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1 * 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 Administered by PFS and AI | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose | PK: Cmax of Mirikizumab administered by PFS and AI. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose | PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI. |
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose | PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirikizumab PFS - Abdomen Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen. | 39 |
| Mirikizumab PFS - Arm Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms. | 39 |
| Mirikizumab PFS - Thigh Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs. | 39 |
| Mirikizumab AI - Abdomen Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen. | 40 |
| Mirikizumab AI - Arm Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms. | 40 |
| Mirikizumab AI - Thigh Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs. | 40 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Mirikizumab PFS - Abdomen | Total | Mirikizumab AI - Thigh | Mirikizumab AI - Arm | Mirikizumab AI - Abdomen | Mirikizumab PFS - Thigh | Mirikizumab PFS - Arm |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 12.7 | 41.3 years STANDARD_DEVIATION 12.9 | 39.1 years STANDARD_DEVIATION 12.8 | 42.6 years STANDARD_DEVIATION 13 | 42.1 years STANDARD_DEVIATION 14.4 | 42.5 years STANDARD_DEVIATION 13.2 | 39.2 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 48 Participants | 8 Participants | 9 Participants | 8 Participants | 13 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 189 Participants | 32 Participants | 31 Participants | 32 Participants | 26 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 29 Participants | 3 Participants | 8 Participants | 4 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 198 Participants | 36 Participants | 29 Participants | 35 Participants | 33 Participants | 33 Participants |
| Region of Enrollment United States | 39 Participants | 237 Participants | 40 Participants | 40 Participants | 40 Participants | 39 Participants | 39 Participants |
| Sex: Female, Male Female | 19 Participants | 138 Participants | 22 Participants | 29 Participants | 21 Participants | 22 Participants | 25 Participants |
| Sex: Female, Male Male | 20 Participants | 99 Participants | 18 Participants | 11 Participants | 19 Participants | 17 Participants | 14 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 / 39 | 0 / 39 | 0 / 39 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 8 / 39 | 13 / 39 | 8 / 39 | 13 / 40 | 9 / 40 | 9 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 | 1 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
PK: Cmax of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Population: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab PFS | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI | 20.0 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 44 |
| Mirikizumab AI | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI | 23.5 micrograms per 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 Administered by PFS and AI
PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Population: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab PFS | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI | 355 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 44 |
| Mirikizumab AI | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI | 411 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 38 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI
PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Population: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Mirikizumab PFS | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI | 359 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 44 |
| Mirikizumab AI | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI | 412 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 39 |