Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants

Study Overview
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Brief Summary
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The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.

Official Title
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A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lutikizumab Dose A
* Drug: Lutikizumab Dose B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female healthy volunteers aged between 18 and 60 years. -- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG). Exclusion Criteria: Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration. History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness. Prior exposure to lutikizumab.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, Dose A<br>Participants will receive a single dose of Lutikizumab Dose A. | Drug: Lutikizumab Dose A<br>* Injection; subcutaneous (SC)<br>|
| Experimental: Part 1, Dose B<br>Participants will receive a single dose of Lutikizumab Dose B. | Drug: Lutikizumab Dose B<br>* Injection; subcutaneous (SC)<br>|
| Experimental: Part 2<br>Han Chinese participants will receive a single dose of Lutikizumab. | Drug: Lutikizumab Dose A<br>* Injection; subcutaneous (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) of Lutikizumab | Cmax of lutikizumab will be assessed. | Up to Day 8 | 
| Time to Cmax (Tmax) of Lutikizumab | Tmax of lutikizumab will be assessed. | Up to Day 8 | 
| Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab | Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed. | Up to Day 8 | 
| Terminal Phase Elimination Half-life (t1/2) of Lutikizumab | Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed. | Up to Day 8 | 
| Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab | AUC0-t of lutikizumab will be assessed. | Up to Day 8 | 
| AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab | AUC0-inf of lutikizumab will be assessed. | Up to Day 8 | 
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lutikizumab