A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: placebo

Drug: lebrikizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423318

GB25741

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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