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: August 4, 2014
Last verified: August 2014
  Purpose

This randomized, double-blind, placebo-controlled, parallel-group study will eva luate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Ja panese 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 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 August 26, 2014