A Phase 1 interventional study of Lebrikizumab and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.
Drug: Lebrikizumab
Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.
Drug: Lebrikizumab
Participants received single dose of placebo administered as SC injection on day 1.
Drug: Placebo
Administered subcutaneously (SC)
Also known as: LY3650150
Administered subcutaneously (SC)
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)
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.
Time frame: Baseline up to 120 days
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab
PK: Cmax of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab
PK: AUC0-∞ of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
PK: AUC0-tlast of Lebrikizumab is reported.
Time frame: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose
| Milestone | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo |
|---|---|---|---|
| Started | 10 | 10 | 4 |
| Received at least one dose of study drug | 10 | 10 | 4 |
| Completed | 10 | 10 | 4 |
| Not completed | 0 | 0 | 0 |
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.
| participants | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo |
|---|---|---|---|
| TEAEs | 10 | 10 | 3 |
| SAEs | 0 | 0 | 0 |
PK: Cmax of Lebrikizumab is reported.
| microgram per millilitre (µg/mL) | 250 mg Lebrikizumab | 500 mg Lebrikizumab |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | 26.8 ± 41.9 | 71.2 ± 22.1 |
PK: AUC0-∞ of Lebrikizumab is reported.
| microgram*day per milliliter (μg*day/mL) | 250 mg Lebrikizumab | 500 mg Lebrikizumab |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab | 1130 ± 42.2 | 2940 ± 11.2 |
PK: AUC0-tlast of Lebrikizumab is reported.
| μg*day/mL | 250 mg Lebrikizumab | 500 mg Lebrikizumab |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | 1080 ± 40.8 | 2800 ± 11.7 |
Collected over Baseline Up to 120 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 250 mg Lebrikizumab | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| 500 mg Lebrikizumab | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Placebo | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 4/10 | 2/10 | 0/4 |
| Mouth ulcerationGastrointestinal disorders | 3/10 | 1/10 | 1/4 |
| Bilirubin conjugated increasedInvestigations | 1/10 | 3/10 | 0/4 |
| Blood creatine phosphokinase increasedInvestigations | 1/10 | 3/10 | 1/4 |
| Neutrophil count increasedInvestigations | 1/10 | 3/10 | 0/4 |
| Noninfective gingivitisGastrointestinal disorders | 0/10 | 0/10 | 1/4 |
| Blood triglycerides increasedInvestigations | 2/10 | 0/10 | 1/4 |
| Urinary occult blood positiveInvestigations | 0/10 | 0/10 | 1/4 |
| Weight increasedInvestigations | 0/10 | 1/10 | 1/4 |
| PresyncopeNervous system disorders | 0/10 | 0/10 | 1/4 |
All enrolled participants who received at least one dose of study drug.
| Age, Continuous(years) | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo | Total |
|---|---|---|---|---|
| Mean | 33.1 ± 8.08 | 29.1 ± 5.95 | 29.0 ± 6.22 | 30.8 ± 6.97 |
| Sex: Female, Male(Participants) | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo | Total |
|---|---|---|---|---|
| Female | 2 | 3 | 2 | 7 |
| Male | 8 | 7 | 2 | 17 |
| Ethnicity (NIH/OMB)(Participants) | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 10 | 4 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 10 | 10 | 4 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 250 mg Lebrikizumab | 500 mg Lebrikizumab | Placebo | Total |
|---|---|---|---|---|
| China | 10 | 10 | 4 | 24 |
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Eli Lilly and Company