A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:August 2011
End Date:February 2012

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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

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
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Honolulu, HI
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