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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243198
• Other study ID #: 18791
• Secondary ID: J2T-MC-KGBV
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lebrikizumab
Administered subcutaneously (SC)
• Placebo
Administered subcutaneously (SC)

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

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