Status:
COMPLETED
A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01423318
Start Date
August 1 2011
End Date
February 1 2012
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Honolulu, Hawaii, United States, 96813