NCT02722122Unknown2 期
A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
Protalix5 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Adverse events following daily administration of AIR DNase™
研究概览
简要总结
This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.
详细描述
This is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg AIR DNase TM administered once daily for 28 days via inhalation to Cystic Fibrosis subjects who have previously been treated with Pulmozyme®.
This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years of age (inclusive) at the time of screening
- •Weight ≥ 36 kg
- •Prior confirmed diagnosis of CF
- •At least 4 months treatment with Pulmozyme® prior to screening.
- •The subject is medically stable for at least one month prior to the screening visit.
- •Stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least four months prior to screening visit.
- •FEV1 of >40% and <90% and FVC ≥ 40% of predicted normal for age, gender, and height at screening .
- •Female and male subjects whose co-partners are of child bearing potential must agree to use two medically acceptable methods of contraception, not including the rhythm method.
- •Be willing and able to adhere to the study visit schedule and other protocol requirements
- •Be willing and able to provide voluntary written informed consent
排除标准
- •Has a history of lung transplantation.
- •Female subjects who are pregnant or lactating.
- •History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
- •History or presence of hypersensitivity or reaction to inhaled proteins.
- •Participation in another clinical trial within 60 days prior to screening.
- •Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's safety or compliance with the requirements of the study.
- •Have positive serology for human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infection.
研究组 & 干预措施
AIR DNase™ 2.5 mg
Experimental
2.5 mg of AIR DNase™ administered once daily via inhalation for 28 days
干预措施: AIR DNase™ (Drug)
结局指标
主要结局
Adverse events following daily administration of AIR DNase™
时间窗: 56 days
Adverse events from subject reporting or other assessments
次要结局
- Change from baseline to end of AIR DNase™ treatment in FEV1(Baseline and 28 days)
- Area under the curve(Up to 4 hours)
- Change from baseline to end of AIR DNase™ treatment in FVC(Baseline and 28 days)
研究者
研究点 (5)
Loading locations...
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