A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01423318
First received: August 22, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: lebrikizumab
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events in healthy Japanese subjects [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]
  • Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: lebrikizumab
Dose-level cohorts receiving single subcutaneous dose
Placebo Comparator: B Drug: placebo
single dose subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423318

Locations
United States, Hawaii
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01423318     History of Changes
Other Study ID Numbers: GB25741
Study First Received: August 22, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014