A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
NCT ID: NCT06243198
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2024-03-28
2024-09-03
Brief Summary
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For each participant, the total duration of the study will be approximately up to 21 weeks, including screening period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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250 mg Lebrikizumab
Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.
Lebrikizumab
Administered subcutaneously (SC)
500 mg Lebrikizumab
Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.
Lebrikizumab
Administered subcutaneously (SC)
Placebo
Participants received single dose of placebo administered as SC injection on day 1.
Placebo
Administered subcutaneously (SC)
Interventions
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Lebrikizumab
Administered subcutaneously (SC)
Placebo
Administered subcutaneously (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2T-MC-KGBV
Identifier Type: OTHER
Identifier Source: secondary_id
18791
Identifier Type: -
Identifier Source: org_study_id
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