A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: lebrikizumab
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult healthy males and females, 18 to 55 years of age inclusive Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation Body weight between 45 and 105 kg, inclusive In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion Negative for hepatitis B, hepatitis C, and HIV infection Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol) Exclusion Criteria: Pregnant and lactating women History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine >500 ng/mL. Minimal/intermittent smoking will be permitted during the study Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1) History of significant, chronic, or recurrent infections requiring treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: lebrikizumab<br>* Dose-level cohorts receiving single subcutaneous dose<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* single dose subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events in healthy Japanese subjects |  | 120 days | 
| Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) |  | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects |  | approximately 5 months | 
| Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects |  | approximately 5 months |