EUCTR2015-002581-23-FR进行中（未招募）1 期
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Documented diagnosis of cystic fibrosis
- •2. =18 and < 65 years of age at the time the Informed Consent Form is signed
- •3. FEV1 = 40% predicted, either pre- or post bronchodilator.
- •4. Stable treatment of cystic fibrosis for 14 days before Visit 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Severe or unstable cystic fibrosis.
- •2. Any of the following values for laboratory tests at Screening
- •a. A positive pregnancy test (also Visit 1)
- •b. Hemoglobin < 10 g/dL
- •c. Neutrophils < 1.0 x 109/L
- •d. Platelets < 500 cells/µL
- •e. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;
- •f. Serum transaminases > 2.5 x upper normal limit
- •g. Total bilirubin = 1.5 x upper limit of normal
- •3. Any other condition that, in the opinion of the site investigator, are clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
研究者
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