A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

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

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.

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