Healthy
Conditions
Brief summary
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be evaluated. The study will last up to 102 days.
Interventions
DRUGLebrikizumab
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
* Are Overtly healthy males or nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation. * Agree not to donate blood or plasma until after the end of their participation in the study * Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
Exclusion criteria
* Are females who are pregnant or lactating. * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Have a history or presence of psychiatric disorders * Show evidence of human immunodeficiency virus infection. * Show evidence of hepatitis C and/or hepatitis B * Medical history of allergic reaction to humanized monoclonal antibodies * 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. * Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or are unable to abide by CRU smoking restrictions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 | PK: Cmax of Lebrikizumab |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 | PK: AUC\[0-∞\] of Lebrikizumab |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 | PK: AUC\[0-tlast\] of Lebrikizumab |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). | 122 |
| Lebrikizumab (Test) - Autoinjector (AI) 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). | 119 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Moved | 1 | 0 |
| Overall Study | Screen Failure - Randomized but Did Not Receive Study Drug | 1 | 0 |
| Overall Study | Unable to comply with study schedule | 0 | 1 |
Baseline characteristics
| Characteristic | Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | Total | Lebrikizumab (Test) - Autoinjector (AI) |
|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 12.6 | 44.7 years STANDARD_DEVIATION 12.9 | 44.1 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 50 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 190 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 55 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 91 Participants | 181 Participants | 90 Participants |
| Region of Enrollment United States | 122 Participants | 241 Participants | 119 Participants |
| Sex: Female, Male Female | 73 Participants | 137 Participants | 64 Participants |
| Sex: Female, Male Male | 49 Participants | 104 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 119 |
| other Total, other adverse events | 39 / 122 | 26 / 119 |
| serious Total, serious adverse events | 0 / 122 | 0 / 119 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab
PK: Cmax of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab | 38.5 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 31 |
| Lebrikizumab (Test) - Autoinjector (AI) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab | 41.9 micrograms per milliliter (µg/mL) | Geometric Coefficient of Variation 31 |
90% CI: [1.03, 1.16]ANCOVA
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab
PK: AUC\[0-∞\] of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | 1340 micrograms*day per milliliter (µg*d/mL) | Geometric Coefficient of Variation 29 |
| Lebrikizumab (Test) - Autoinjector (AI) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | 1450 micrograms*day per milliliter (µg*d/mL) | Geometric Coefficient of Variation 26 |
90% CI: [1.02, 1.14]ANCOVA
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
PK: AUC\[0-tlast\] of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | 1250 µg*d/mL | Geometric Coefficient of Variation 28 |
| Lebrikizumab (Test) - Autoinjector (AI) | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | 1360 µg*d/mL | Geometric Coefficient of Variation 25 |
90% CI: [1.03, 1.14]ANCOVA