NCT05238532撤回1 期
A Multi-center, Open-label Dose-escalation and Dose-finding Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Acute Respiratory Distress Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Adverse Drug Reaction incidence rate
研究概览
简要总结
Evaluate the safety, tolerability, efficacy and pharmacodynamics&pharmacokinetic properties of CT303 in patients with ARDS.
详细描述
This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial.
The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS. And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 19 years old
- •Patients who meet the ARDS criteria according to the Berline definition
- •within 1 week of a known clinical insult or new or worsening respiratory symtoms
- •Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
- •Respiratory failure not fully explained by cardiac failure or fluid overload
- •oxygenation corresponding to mild, moderate, severe
- •Patients requiring positive pressure ventilation using an endotracheal tube
- •Patients or legal representative signed Informed consent form
排除标准
- •Greater than 96 hours since first meeting ARDS criteria
- •Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products
- •Patients with the following medical history or comorbid condition
- •medical history
- •Patients who had an organ transplant or bone-marrow transplantation
- •Patients who had a pneumonectomy
- •a maligant tumor within 5 years
- •a deep vein thrombosis or pulmonary embolism with in 6 months
- •a trauma within 7 days
- •comorbid condition
- •Patients with AST or ALT exceeding 5 times the upper limit of the normal range
- •eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
- •severe chronic respiratory disease
- •WHO functional assessment class III/IV pulmonary hypertension
- •Severe cardiac insufficiency
- •QTc > 480msec
- •chronic underlying diseases
- •viral hepatitis type B or type C, or positive HIV test
- •Patients using extracorporeal life support devices or high-frequency oscillatory ventilation
- •Moribund patients expected to die within 48 hours
- •Patients who refuse or are likely to refuse life-sustaining treatment
- •Fertile women or men who disagree a continence and a contraception
- •Patients with a history of hypersensitivity reaction
- •Patients participating in clinical trials within 4 weeks
- •Patients determined by the investigator to be inappropriate to participate in this clinical trial
结局指标
主要结局
Adverse Drug Reaction incidence rate
时间窗: Day 0 to Day 28
Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.
次要结局
未报告次要终点
研究者
研究点 (6)
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