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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06243198

18791

J2T-MC-KGBV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

250 mg Lebrikizumab

Experimental group

Description:

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

Treatment:

Drug: Lebrikizumab

500 mg Lebrikizumab

Experimental group

Description:

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

Treatment:

Drug: Lebrikizumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo