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A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423318
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: lebrikizumab Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: A Drug: lebrikizumab
Dose-level cohorts receiving single subcutaneous dose

Placebo Comparator: B Drug: placebo
single dose subcutaneously

Primary Outcome Measures :
  1. Safety: Incidence of adverse events in healthy Japanese subjects [ Time Frame: 120 days ]
  2. Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) [ Time Frame: 120 days ]

Secondary Outcome Measures :
  1. Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ]
  2. Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423318

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United States, Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.

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Responsible Party: Genentech, Inc. Identifier: NCT01423318     History of Changes
Other Study ID Numbers: GB25741
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs