Healthy
Conditions
Keywords
Pharmacokinetics, Safety, Lebrikizumab, Chinese
Brief summary
The main purpose of this study is to determine the tolerability and side effects related to lebrikizumab comparing with placebo given as a single dose administered under the skin to healthy Chinese participants. The study will also assess how fast lebrikizumab gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either Lebrikizumab or placebo. For each participant, the total duration of the study will be approximately up to 21 weeks, including screening period.
Interventions
DRUGLebrikizumab
Administered subcutaneously (SC)
DRUGPlacebo
Administered subcutaneously (SC)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be overtly healthy, as determined by medical evaluation. * Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study. * Participants must be native Chinese and born in China, where the participant's biological parents and all 4 of the participant's biological grandparents are of Chinese origin. * Have a body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m²). * Have venous access sufficient to allow for blood sampling.
Exclusion criteria
* Have known allergies to Lebrikizumab, related compounds, or any components of the formulation. * Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data. * Have a history or presence of psychiatric disorders. * Have a history or presence of multiple or severe drug allergies. * Have significant allergies to monoclonal antibodies. * Show evidence of active or latent TB, human immunodeficiency virus infection ,hepatitis B and C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | Baseline up to 120 days | A TEAE is defined as an AE that starts during or after dosing, or starts prior to dosing and increases in severity after dosing. A SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may require medical or surgical intervention to prevent any of the above outcomes. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose | PK: Cmax of Lebrikizumab is reported. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose | PK: AUC0-∞ of Lebrikizumab is reported. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose | PK: AUC0-tlast of Lebrikizumab is reported. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 250 mg Lebrikizumab Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1. | 10 |
| 500 mg Lebrikizumab Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. | 10 |
| Placebo Participants received single dose of placebo administered as SC injection on day 1. | 4 |
| Total | 24 |
Baseline characteristics
| Characteristic | 500 mg Lebrikizumab | Total | Placebo | 250 mg Lebrikizumab |
|---|---|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 5.95 | 30.8 years STANDARD_DEVIATION 6.97 | 29.0 years STANDARD_DEVIATION 6.22 | 33.1 years STANDARD_DEVIATION 8.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 24 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 24 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 10 Participants | 24 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 17 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 10 / 10 | 10 / 10 | 3 / 4 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 4 |
Outcome results
Primary
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
A TEAE is defined as an AE that starts during or after dosing, or starts prior to dosing and increases in severity after dosing. A SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may require medical or surgical intervention to prevent any of the above outcomes. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.
Time frame: Baseline up to 120 days
Population: All enrolled participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 250 mg Lebrikizumab | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAEs | 10 participants |
| 250 mg Lebrikizumab | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAEs | 0 participants |
| 500 mg Lebrikizumab | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAEs | 10 participants |
| 500 mg Lebrikizumab | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAEs | 0 participants |
| Placebo | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAEs | 3 participants |
| Placebo | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | SAEs | 0 participants |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab
PK: Cmax of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg Lebrikizumab | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | 26.8 microgram per millilitre (µg/mL) | Geometric Coefficient of Variation 41.9 |
| 500 mg Lebrikizumab | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | 71.2 microgram per millilitre (µg/mL) | Geometric Coefficient of Variation 22.1 |
Secondary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab
PK: AUC0-∞ of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg Lebrikizumab | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab | 1130 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 42.2 |
| 500 mg Lebrikizumab | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab | 2940 microgram*day per milliliter (μg*day/mL) | Geometric Coefficient of Variation 11.2 |
Secondary
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
PK: AUC0-tlast of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 250 mg Lebrikizumab | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | 1080 μg*day/mL | Geometric Coefficient of Variation 40.8 |
| 500 mg Lebrikizumab | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | 2800 μg*day/mL | Geometric Coefficient of Variation 11.7 |