NCT00581997终止2 期
A Randomized, Double-blinded, Placebo Controlled, Multiple-dose, Multi-center Pilot Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Doses of QAX576 in Patients With Pulmonary Fibrosis Secondary to System Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 主要终点
- - Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
研究概览
简要总结
This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
- •Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening
排除标准
- •Certain medical conditions may exclude patients from participation.
- •Should not have participated in another clinical study within 4 weeks of study start
- •Smokers are not eligible for participation
- •Blood loss of donation of 400 mL or more within 2 months of study start
- •Pregnant women or women who are breast feeding
- •Past medical history of clinically significant ECG abnormalities
- •Connective tissue disorders other than systemic sclerosis.
- •Active infection or history of systemic parasitic infection
- •History of immunodeficiency diseases, including a positive HIV test result
- •History of drug or alcohol abuse within 12 months of study start
- •Any condition that may compromise patient safety
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
QAX576
干预措施: QAX576 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
时间窗: throughout the study
次要结局
- - The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS.(throughout the study)
研究者
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终止
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