A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: placebo; Drug: lebrikizumab

• Registration Number: NCT01423318
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	-
A	lebrikizumab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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