A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: lebrikizumab; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: lebrikizumab; Dose-level cohorts receiving single subcutaneous dose
Placebo Comparator: B	Drug: placebo; single dose subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: August 22, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (Estimate): August 25, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GB25741