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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGBV | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg Lebrikizumab | Experimental | Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1. |
|
| 500 mg Lebrikizumab | Experimental | Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. |
|
| Placebo | Placebo Comparator | Participants received single dose of placebo administered as SC injection on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | PK: Cmax of Lebrikizumab is reported. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 250 mg Lebrikizumab | Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1. |
| FG001 | 500 mg Lebrikizumab | Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. |
| FG002 | Placebo | Participants received single dose of placebo administered as SC injection on day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 250 mg Lebrikizumab | Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1. |
| BG001 | 500 mg Lebrikizumab | Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Baseline up to 120 days |
|
Baseline Up to 120 Days
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 250 mg Lebrikizumab | Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2023 | Jul 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2024 | Jul 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| Placebo | Drug | Administered subcutaneously (SC) |
|
PK: AUC0-∞ of Lebrikizumab is reported. |
| 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. | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose |
| BG002 | Placebo | Participants received single dose of placebo administered as SC injection on day 1. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1. |
| OG001 | 500 mg Lebrikizumab | Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. |
| OG002 | Placebo | Participants received single dose of placebo administered as SC injection on day 1. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | PK: Cmax of Lebrikizumab is reported. | All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per millilitre (µg/mL) | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab | PK: AUC0-∞ of Lebrikizumab is reported. | All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/mL) | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*day/mL | Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | 500 mg Lebrikizumab | Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1. | 0 | 10 | 0 | 10 | 10 | 10 |
| EG002 | Placebo | Participants received single dose of placebo administered as SC injection on day 1. | 0 | 4 | 0 | 4 | 3 | 4 |
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Noninfective gingivitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Urinary occult blood positive | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Urobilinogen urine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
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