JPRN-UMIN000022116已完成1 期
SK-1401 (rhGM-CSF agent for inhalation) GM-CSF Inhalation Pharmacokinetic study (NTU Trial) - SK-1401 (rhGM-CSF agent for inhalation) GM-CSF Inhalation Pharmacokinetic study (NTU Trial)
iigata University Medical and Dental Hospital Bioscience Medical Reseach Center0 个研究点目标入组 14 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. WBC of 12000/ul or more 2. Fever of 38 degree celsius or more 3. History of malignant disease within recent 5 years (not applied to the treatedcases of local basal cell carcinoma) 4. Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc. 5. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), interstitial pneumonitis, lung fibrosis or bronchiectasis, in which the evaluations of safety of GM-CSF therapy are considered to be difficult. 6. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks. 7. liver dysfunction (CTCAE Grade 1 or higher) 8. renal dysfunction (CTCAE Grade 1 or higher) 9. Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product 10. Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA 11. allergic to GM-CSF. 12. addicted to illegal drugs 13. Participation to other clinical trials within 12 weeks before registration. 14. smoking within 5 years 15.cannot follow the procedure defined in this protocol aPAP patient must exclude the following 16. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period 17. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, GM-CSF or rituximab within 6 months before the start of the study. 18. taking other inhalation. Healthy volunteer must exclude the following 19.taking any prescribed medicines.
研究者
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