NCT00421226已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Demonstrate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered as Intravenous Infusion and Subcutaneous Injection in Japanese Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.
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
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese healthy male subjects age 20 to 45 years of age, and in good health
- •At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
- •Body mass index within the range of 18 to 28 kg/m2 and weigh 50 to 100 kg
排除标准
- •Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable. Treatment of any biologics within three months prior to dosing. Having live vaccinations within six months prior to dosing.
- •Participation in any clinical investigation within 4 months prior to dosing.
- •Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to participation.
- •Significant illness (sinusitis, pneumonia, cystitis, sepsis, etc) within two weeks prior to dosing.
- •A past personal or close family medical history of cardiac disorders
- •History of:
- •fainting,
- •low blood pressure when standing,
- •abnormal heart rhythms
- •acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- •Clinically significant drug allergy or history and complication of atopic allergy (asthma, urticaria, eczematous dermatitis)
- •Known hypersensitivity to the study drug or similar drugs
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
- •History of immunodeficiency diseases, including a positive HIV test result.
- •A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
- •Drug or alcohol abuse within the 12 months prior to dosing
- •Tuberculosis symptoms, complication of tuberculosis, contact with patients with suspected tuberculosis symptoms
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Safety and tolerability
次要结局
- Pharmacokinetics and pharmacodynamics
研究者
研究点 (1)
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