A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 27
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
详细描述
An interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in 70 subjects ≥ 18 and < 65 years of age with documented cystic fibrosis. There will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
- •Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test;
- •Two well-characterized mutations in the CFTR gene
- •FEV1 ≥ 40% predicted corrected
- •Stable treatment of CF for 14 days before Visit 1
排除标准
- •Severe or unstable CF, such as:
- •Intravenous antibiotic treatment within 14 days before Visit 1
- •Treatment with any corticosteroids > 10 mg per day or > 20 mg every other day oral prednisone or equivalent within 14 days before Visit 1
- •Any one of the following values for laboratory tests at Screening:
- •A positive pregnancy test (or at Visit 1);
- •Hemoglobin < 10 g/dL
- •Neutrophils < 1.0 x 10~9/L
- •Platelets < 75 x 10~9/L
- •Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation
- •Serum transaminases > 2.5 x upper normal limit
- •Total bilirubin ≥ 1.5 x upper limit of normal
- •Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
研究组 & 干预措施
JBT101 (lenabasum) 1 mg
JBT-101 1 mg once a day on Days 1-28
干预措施: JBT-101 (lenabasum) (Drug)
JBT-101 (lenabasum) 5 mg
JBT-101 5 mg once a day on Days 1-28
干预措施: JBT-101 (lenabasum) (Drug)
Placebo
Placebo once a day on Days 1-28.
干预措施: Placebo (Other)
JBT-101 (lenabasum) 20 mg QD
JBT-101 20 mg once a day on Days 29-84.
干预措施: JBT-101 (lenabasum) (Drug)
JBT-101 (lenabasum) 20 mg BID
JBT-101 20 mg twice daily on Days 29-84.
干预措施: JBT-101 (lenabasum) (Drug)
Placebo BID
Placebo twice daily on Days 29-84.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events.
时间窗: 84 days of treatment
次要结局
- JBT-101 (Lenabasum) Plasma Concentrations on Day 84(Day 84)