Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sequence matched median PaO2 per dose cohort comparing TSC vs PBO
研究概览
简要总结
This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females ages 18-40
- •Non-smoking
- •Able to provide informed consent and agree to adhere to all study visits and requirements.
- •Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
- •Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug
排除标准
- •Allergy to study medication
- •Pregnant or breast feeding
- •Received investigational medicine (IMP) within past 30 days
- •VO2 max < 35 mL/kg/min (male), < 30 mL/kg/min (female) at screening
- •Abnormal pulmonary function testing at screening
- •Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
- •History of ongoing alcohol or substance abuse
- •Known cardiovascular disease, including treated or untreated hypertension
- •Respiratory disease and/or any other significant medical condition, including psychiatric disorders
- •Clinically significant abnormality on ECG per PI discretion
- •Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
- •Plasma donation within 7 days prior to screening
- •Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
- •History of smoking
- •Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
- •History of seizures
- •Previous pneumothorax or pneumomediastinum
- •Hypo/Hyperglycemia
- •Regularly taking medications which may alter heart rate, blood pressure or cardiac output
- •Previous history of middle ear equalization problems at discretion of PI
研究组 & 干预措施
0.5 mg/kg Trans Sodium Crocetinate
Subjects will receive a single IV bolus dose of 0.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.
干预措施: Trans Sodium Crocetinate (Drug)
1.5 mg/kg Trans Sodium Crocetinate
Subjects will receive a single IV bolus dose of 1.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.
干预措施: Trans Sodium Crocetinate (Drug)
2.5 mg/kg Trans Sodium Crocetinate
Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC. Subjects will also receive a single IV dose of normal saline as placebo, thereby serving as their own control.
干预措施: Trans Sodium Crocetinate (Drug)
结局指标
主要结局
Sequence matched median PaO2 per dose cohort comparing TSC vs PBO
时间窗: Up to 10 ± 1 minutes after final VO2 max
Comparison of partial pressure of oxygen (PaO2) at altitude between control and experimental exposures
Sequence matched median VO2 per dose cohort comparing TSC vs PBO
时间窗: Up to 33 minutes (achievement of peak wattage)
Comparison of maximal oxygen consumption (VO2 max) at altitude between control and experimental exposures
次要结局
- Effect of TSC on Median Oxygen Saturation(Up to 33 minutes (achievement of peak wattage))
- Effect of TSC on Median Serum Lactate Concentration(Up to 33 minutes (achievement of peak wattage))