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

Genentech, Inc.0 sites60 target enrollmentAugust 2011

ConditionsHealthy Volunteer

Interventionslebrikizumab placebo

Drugslebrikizumab placebo

Overview

Phase: Phase 1
Intervention: lebrikizumab
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 60
Primary Endpoint: Safety: Incidence of adverse events in healthy Japanese subjects
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

February 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: lebrikizumab

B

Intervention: placebo

Outcomes

Primary Outcomes

Safety: Incidence of adverse events in healthy Japanese subjects

Time Frame: 120 days

Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)

Time Frame: 120 days

Secondary Outcomes

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)