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Completed

NCT Number: NCT06243198

A 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lebrikizumab

Drug

Administered subcutaneously (SC)

Other names: LY3650150

Placebo

Drug

Administered subcutaneously (SC)

Primary outcomes

  1. Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab

    Time frame: 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.

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab

    Time frame: 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.

  3. PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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