Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuro… (NCT06945614) | Clinical Trial Compass
RecruitingPhase 1
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
United States16 participantsStarted 2025-04-16
Plain-language summary
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.
Who can participate
Age range55 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 55-75 years.
✓. Good general health with no disease likely to interfere with the study assessments.
✓. Baseline vital signs within the following ranges:
✓. resting heart rate 60 to 90 BPM with Normal Sinus Rhythm
✓. respiratory rate less than 14
✓. resting diastolic blood pressure greater than 60 mm Hg and less than 90 mm Hg and resting systolic blood pressure less than 140 mm Hg and more than 110 mm Hg
✓. Peripheral blood oxygen saturation \>95%
✓. Immunizations fully up to date at Screening, according to the assessment of their primary care physician.
Exclusion criteria
✕. Body mass index \>30.
✕. Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.
What they're measuring
1
Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0
Timeframe: From treatment to the end of follow up at 7 days