A Proof-of-Concept, Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation in Healthy Human Subjects
General Biophysics LLC
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.
Description
The investigators plan to find out if xenon gas can help people with Alzheimer's disease, but it needs to be studied in healthy volunteers first. This study will show if xenon gas is safe to take without causing too many side effects. Xenon gas is not approved by the U.S. Food and Drug Administration (FDA). This means that the use of xenon gas is investigational and can only be used in research studies. This single-center, open-label study will evaluate the safety and efficacy of xenon gas inhalation for 4 different durations of administration in healthy subjects. The study will be conducted…
Eligibility
- Age range
- 55–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Study subjects must meet the following eligibility criteria to participate in the study. 1. Male or female, aged 55-75 years. 2. Good general health with no disease likely to interfere with the study assessments. 3. Baseline vital signs within the following ranges: 1. resting heart rate 60 to 90 BPM with Normal Sinus Rhythm 2. respiratory rate less than 14 3. 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 4. Peripheral blood oxygen saturation \>95% 4…
Interventions
- DrugXenon gas inhalation
Administration of xenon gas in the mixture with oxygen for the period of time via inhalation
Location
- Brigham and Women's HospitalBoston, Massachusetts