NCT06658535招募中1 期
Novel Oxygen Therapeutic NanO2 for Mild Respiratory Distress in Phase 1b
NuvOx LLC2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年3月13日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
- •Admitted to a hospital with symptoms of mild RD
- •Signed informed consent obtained from the subject or subject's legally authorized representative
- •Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28
排除标准
- •Presence of extracorporeal membrane oxygenation
- •Unstable hypertension
- •History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
- •Presence of pulmonary embolism at baseline
- •Evidence of right ventricular heart failure
- •Unstable hemodynamically as defined by receiving 0.5μg/kg/min or greater norepinephrine
- •Inability to comply with the study procedures
- •Currently pregnant or breastfeeding
- •Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours
- •History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion
研究组 & 干预措施
Cohort 0.025
Experimental
Loading dose = 0.025 mL/kg followed sustained IV infusion of 0.375 mL/kg over 21 hours.
干预措施: dodecafluoropentane (0.025 mL/kg) (Drug)
Cohort 0.032
Experimental
Loading dose of 0.032 mL/kg followed sustained IV infusion of 0.48 mL/kg over 21 hours.
干预措施: dodecafluoropentane (0.032 mL/kg) (Drug)
Cohort 0.050
Experimental
Loading dose of 0.050 mL/kg followed by sustained IV infusion of 0.75 mL/kg over 21 hours.
干预措施: dodecafluoropentane (0.050 mL/kg) (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 28 Days
To determine the Maximum Tolerated Dose of NanO2 in subjects with Mild Respiratory Distress.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](28 days)
研究者
研究点 (2)
Loading locations...
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