Clinical trial NCT06243198: A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Safety
Lebrikizumab
Chinese
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline up to 120 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab
timeFrame: Predose up to Day 120
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab
timeFrame: Predose up to Day 120
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
timeFrame: Predose up to Day 120
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: