NCT02840708已完成1 期
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
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
- 14
- 试验地点
- 1
- 主要终点
- Serum level of Sargramostim
研究概览
简要总结
Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.
Study Design: Pharmacokinetic open study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects judged to be appropriate for the study by the attending physician
- •can provide signed informed consent.
- •aPAP patient must meet the following
- •aPAP patient aged over 20 and below 80 years old (as of the date of registration)
- •aPAP severity is mild or moderate. (not severe)
- •Healthy volunteer must meet the following
- •Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
- •BMI (Body mass index) is between 18 and 25.
排除标准
- •WBC of 12,000/mcl or more
- •Fever of 38 degree celsius or more
- •History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
- •Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
- •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.
- •History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
- •liver dysfunction
- •renal dysfunction
- •Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
- •Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
- •allergic to GM-CSF.
- •addicted to illegal drugs
- •Participation to other clinical trials within 12 weeks before registration.
- •smoking within 5 years
- •cannot follow the procedure defined in this protocol
- •aPAP patient must exclude the following
- •Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
- •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.
- •taking other inhalation.
- •Healthy volunteer must exclude the following
- •taking any medicines (incl. OTC).
研究组 & 干预措施
125mcg
Active Comparator
SK-1401 125mcg single inhalation
干预措施: Sargramostim (Drug)
250mcg
Active Comparator
SK-1401 250mcg single inhalation
干预措施: Sargramostim (Drug)
500mcg
Active Comparator
SK-1401 500mcg single inhalation
干预措施: Sargramostim (Drug)
结局指标
主要结局
Serum level of Sargramostim
时间窗: 0.5,1,2,4,8,12 and 24 hours after inhalation
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
SK-1401 (rhGM-CSF agent for inhalation) GM-CSF Inhalation Pharmacokinetic study (NTU Trial)autoimmune pulmonary alveolar proteinosisJPRN-UMIN000022116iigata University Medical and Dental Hospital Bioscience Medical Reseach Center14
撤回
1 期
Inhaled GM-CSF for Respiratory Virus-Associated Severe PneumoniaPneumoniaRespiratory Virus InfectionAcute Respiratory Distress SyndromeNCT02601365Milton S. Hershey Medical Center
已完成
1 期
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.Pulmonary Disease, Chronic ObstructiveNCT00453687GlaxoSmithKline12
已完成
1 期
SK-5307 P I single-dose study.JPRN-jRCT2071220045Kenji Asano38
已完成
1 期
Single Dose Study of GSK1440115 in Patients With AsthmaAsthmaNCT01424280Accenture12