NCT01423318已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Safety: Incidence of adverse events in healthy Japanese subjects
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
A
Experimental
干预措施: lebrikizumab (Drug)
B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events in healthy Japanese subjects
时间窗: 120 days
Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC)
时间窗: 120 days
次要结局
- Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects(approximately 5 months)
- Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects(approximately 5 months)
研究者
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