Honolulu, Hawaii, 96813, United States
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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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugDose-level cohorts receiving single subcutaneous dose
Placebo
Drugsingle dose subcutaneously
Primary outcomes
-
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
Secondary outcomes
-
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
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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