Clinical trial NCT01423318: A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.


Eligibility 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

Primary outcomes:
measure: Safety: Incidence of adverse events in healthy Japanese subjects
timeFrame: 120 days
measure: Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)
timeFrame: 120 days
Secondary outcomes:
measure: Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects
timeFrame: approximately 5 months
measure: Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects
timeFrame: approximately 5 months
Other outcomes:
Locations:
city: Honolulu
country: United States
state: Hawaii
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: