Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGlebrikizumab
Dose-level cohorts receiving single subcutaneous dose
DRUGplacebo
single dose subcutaneously
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed