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

A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lebrikizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 250 mg Lebrikizumab; Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.	Drug: Lebrikizumab; Administered subcutaneously (SC); Other Names: LY3650150
Experimental: 500 mg Lebrikizumab; Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Drug: Lebrikizumab; Administered subcutaneously (SC); Other Names: LY3650150
Placebo Comparator: Placebo; Participants received single dose of placebo administered as SC injection on day 1.	Drug: Placebo; Administered subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab	PK: Cmax of Lebrikizumab is reported.	Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab	PK: AUC0-∞ of Lebrikizumab is reported.	Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
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.	Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Chinese; Pharmacokinetics; Lebrikizumab
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; lebrikizumab
• Other Study ID Numbers: 18791; J2T-MC-KGBV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes