The goal of this clinical study is to evaluate safety of Xenon gas inhalation in healthy volunteers. This first phase safety clinical study is part of evaluation of the xenon gas inhalation as a therapy for neurodegenerative diseases, such as Alzheimer's disease.
The investigators will administer xenon gas in low concentration to people via anesthetic machine, observe participants for sedation and any unexpected side effects, collect blood at each visit and measure the vital signs. There are four treatment groups in the study, which correspond with the duration of xenon gas treatment. Individual participation will last approximately 14 days over five visits: screening visit accompanied by the electrocardiogram, blood, and urine test; treatment visit for xenon gas inhalation treatment; and three follow up visits.
Male or female, aged 55-75 years.
Good general health with no disease likely to interfere with the study assessments.
resting heart rate 60 to 90 BPM with Normal Sinus Rhythm
respiratory rate less than 14
Body mass index >30.
Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.
Active SARS-CoV-2 (COVID-19) disease.
A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
Sequential
Xenon gas inhalation
DrugAdministration of xenon gas in the mixture with oxygen for the period of time via inhalation
Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0
To determine the safety of xenon gas inhalation for 10, 20, 30, and 45 minutes in healthy volunteers. Investigators anticipate to observe no sedation, no nausea, and no vomiting. Measured Parameters for Safety Assessments during Xenon Administration (Intraoperative - every five (5) minutes): * Heart rate * Blood pressure * Respiratory rate * Body temperature * Peripheral blood oxygenation * Changes in capnometry * Electrocardiographic parameters and printed rhythm strip * Adverse events Depth of sedation will be assessed and recorded every five (5) minutes during Xenon Gas administration and upon completion of procedure and recovery, utilizing the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) by the anesthesiologist. Adverse events of special interest for this inhaled anesthetic: vomiting, hemodynamic changes requiring drug intervention, and sedation unresponsive to verbal commands. AEs will be assessed during repeated visits on day 1, day 3, and day 7.
Number of Participants With Treatment Related Change in Blood Biomarkers From the Baseline.
Depending on the duration of the xenon inhalation treatment and time after the treatment (immediately, 1 day, 3 days, and 7 days) the blood biomarkers will be measured. We anticipate to see the effect of xenon inhalation on immune cells as well as cytokines and hormones panels for the plasma samples. Specifically, the change from the baseline in the number and phenotypes of blood monocytes, Natural Killer Cells (NK), B cells, CD4, CD8 T cells and neutrophils will be measured. In addition the change from the baseline in cytokines and hormone levels in the plasma samples will be measured.
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General Biophysics LLC
Lead sponsor
National Institute on Aging (NIA)
Collaborator
