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.

August 22, 2011
August 25, 2011
November 2, 2016
August 2011
February 2012   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01423318 on Archive Site
  • Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ]
  • Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ]
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: lebrikizumab
    Dose-level cohorts receiving single subcutaneous dose
  • Drug: placebo
    single dose subcutaneously
  • Experimental: A
    Intervention: Drug: lebrikizumab
  • Placebo Comparator: B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP