A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

Phase 1

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
250 mg Lebrikizumab	Lebrikizumab	Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.
500 mg Lebrikizumab	Lebrikizumab	Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.
Placebo	Placebo	Participants received single dose of placebo administered as SC injection on day 1.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): Peking University People's Hospital
🇨🇳
Beijing, Beijing Municipality, China
Peking University People's Hospital
🇨🇳Beijing, Beijing Municipality, China