Healthy Clinical Trial
Official title:
A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to 120 days | |
Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab | PK: Cmax of Lebrikizumab | Predose up to Day 120 | |
Secondary | PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-8]) of Lebrikizumab | PK: AUC0-8 of Lebrikizumab | Predose up to Day 120 | |
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 | Predose up to Day 120 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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