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

Recruiting
18 - 65 years of age
Both
Phase 1

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Overview

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.

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.

Study details

Healthy

NCT06243198

Eli Lilly and Company

29 April 2024

Step 1 Get in touch with the nearest study center
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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