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OpenTrials
Completed

NCT Number: NCT01423318

A Study 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lebrikizumab

Drug

Dose-level cohorts receiving single subcutaneous dose

Placebo

Drug

single dose subcutaneously

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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