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

NCT06243198 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18791J2T-MC-KGBV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Safety; Lebrikizumab; Chinese

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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: 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: 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

Study Arms (3)

250 mg Lebrikizumab

EXPERIMENTAL

Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.

Drug: Lebrikizumab

500 mg Lebrikizumab

EXPERIMENTAL

Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.

Drug: Lebrikizumab

Placebo

PLACEBO COMPARATOR

Participants received single dose of placebo administered as SC injection on day 1.

Drug: Placebo

Interventions

Lebrikizumab DRUG

Administered subcutaneously (SC)

Also known as: LY3650150

250 mg Lebrikizumab; 500 mg Lebrikizumab

Placebo DRUG

Administered subcutaneously (SC)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

lebrikizumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: March 28, 2024
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)