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A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

NCT ID: NCT01423318

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

lebrikizumab

Intervention Type DRUG

Dose-level cohorts receiving single subcutaneous dose

B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose subcutaneously

Interventions

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lebrikizumab

Dose-level cohorts receiving single subcutaneous dose

Intervention Type DRUG

placebo

single dose subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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GB25741

Identifier Type: -

Identifier Source: org_study_id