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NCT06243198

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

Completed Phase 1 Results posted Last updated 12 September 2025
What this trial tests

Phase 1 trial testing Lebrikizumab in Healthy in 24 participants. Completed in 3 September 2024.

Timeline
28 March 2024
Primary endpoint
3 September 2024
3 September 2024

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposebasic science
Enrollment24
Start date28 March 2024
Primary completion3 September 2024
Estimated completion3 September 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Primary · 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 no

TEAEs
GroupValue95% CI
250 mg Lebrikizumab10
500 mg Lebrikizumab10
Placebo3
SAEs
GroupValue95% CI
250 mg Lebrikizumab0
500 mg Lebrikizumab0
Placebo0
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab Secondary · 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.

GroupValue95% CI
250 mg Lebrikizumab26.8± 41.9
500 mg Lebrikizumab71.2± 22.1
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab Secondary · 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.

GroupValue95% CI
250 mg Lebrikizumab1130± 42.2
500 mg Lebrikizumab2940± 11.2
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab Secondary · 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.

GroupValue95% CI
250 mg Lebrikizumab1080± 40.8
500 mg Lebrikizumab2800± 11.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline Up to 120 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

250 mg Lebrikizumab
Serious: 0/10 (0%)
Deaths: 0/10
500 mg Lebrikizumab
Serious: 0/10 (0%)
Deaths: 0/10
Placebo
Serious: 0/4 (0%)
Deaths: 0/4
Other adverse events (31 terms — click to expand)

ReactionSystem250 mg Lebrikizumab500 mg LebrikizumabPlacebo
Upper respiratory tract infectionInfections and infestations
Mouth ulcerationGastrointestinal disorders
Bilirubin conjugated increasedInvestigations
Blood creatine phosphokinase increasedInvestigations
Neutrophil count increasedInvestigations
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Blood triglycerides increasedInvestigations
EosinophiliaBlood and lymphatic system disorders
Dry eyeEye disorders
DiarrhoeaGastrointestinal disorders
Noninfective gingivitisGastrointestinal disorders
FolliculitisInfections and infestations
HordeolumInfections and infestations
Blood bilirubin increasedInvestigations
Blood uric acid increasedInvestigations
Eosinophil count increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
Urinary occult blood positiveInvestigations
Urine ketone body presentInvestigations
Urobilinogen urine increasedInvestigations
Weight decreasedInvestigations
Weight increasedInvestigations
White blood cell count decreasedInvestigations
PresyncopeNervous system disorders
InsomniaPsychiatric disorders
AcneSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT06243198 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lebrikizumab

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06243198.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing