Phase 1 Completed N=24 Randomized Double-blind Basic Science

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

Healthy

Source: ClinicalTrials.gov NCT06243198 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcomePrimary: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) — 10; 10; 3; 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)	10; 10; 3; 0; 0; 0	—
SECONDARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab	26.8; 71.2	—
SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab	1130; 2940	—
SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab	1080; 2800	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06243198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.