NCT01057498已完成1 期
A Phase I Study of Nebulized RNS60 in Adult Healthy Subjects and Patients With Mild to Moderate Asthma.
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
- 36
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The purpose of this study is two-fold. First, to determine whether nebulized RNS60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. Second, to determine whether nebulized RNS60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •For single-dose safety (Groups 1a and 1b):
- •Male or female, aged 18 to 65 years.
- •For healthy subjects; clinically considered "healthy" and no diagnosis of asthma.
- •For subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by National Heart, Lung, and Blood Institute's (NHLBI) 2007 guidelines, and who are not regularly using a chronic asthma medication (< 3 doses/week).
- •Subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.
- •Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.
- •For multi-dose safety study (Group 2e):
- •Male or female, aged 18 to 65 years.
- •Patients with clinical diagnosis of mild to moderate asthma, as determined by NHLBI 2007 guidelines, who are not already using a chronic asthma medication.
- •Historical documentation of asthma in the patient's medical record.
- •Men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (Day 28).
- •Women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry.
- •Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent.
- •Exclusion Criteria (for all groups of the study):
- •With a chronic or acute disease that might interfere with the evaluation of RNS60 therapy.
- •Pregnancy or lactation.
- •Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated).
- •History of infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV).
- •Infections that require intravenous antibiotic therapy.
- •Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry).
- •Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
- •Treatment with any investigational drugs or therapies within 4 weeks prior to study entry.
- •Any use of antidepressants or other psychiatric medicine in the previous 4 weeks days.
- •Group 1b: Any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. Group 2e: Any use of oral, systemic corticosteroids within 4 weeks prior to enrollment.
排除标准
- 未提供
研究组 & 干预措施
1a - RNS60 in Healthy Subjects
Experimental
Single dose administration of nebulized RNS60 testing for bronchoconstriction in healthy human subjects.
干预措施: RNS60 - single dose (Drug)
1b: RNS60 in Mild Asthmatics
Experimental
Single-dose administration of nebulized RNS60 testing for bronchoconstriction in mild asthmatics.
干预措施: RNS60 - single dose (Drug)
2e: RNS60 in mild-to-moderate asthmatics
Experimental
RNS60 in mild-to-moderate asthmatics who are not currently taking a chronic asthma medication.
干预措施: RNS60 (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1)
时间窗: 28 days
Evidence that nebulized RNS60 does not cause bronchoconstriction in subjects with mild-to-moderate asthma, as measured by weekly FEV1 scores over 28 days.
次要结局
- Quality of life(28 days)
- Peak expiratory flow(28 days)
研究者
研究点 (2)
Loading locations...
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