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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01423318 |
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Date of registration:
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22/08/2011 |
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Primary sponsor: |
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Public title:
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A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01423318 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genentech |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteer
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Intervention(s)
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Drug: lebrikizumab
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Drug: placebo
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Primary Outcome(s)
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Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)
[Time Frame: 120 days]
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Safety: Incidence of adverse events in healthy Japanese subjects
[Time Frame: 120 days]
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Secondary Outcome(s)
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Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects
[Time Frame: approximately 5 months]
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Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects
[Time Frame: approximately 5 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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