Actively Recruiting
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
Led by General Biophysics LLC · Updated on 2025-04-25
16
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
G
General Biophysics LLC
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 55 to 75 years
- Good general health without diseases affecting study assessments
- Resting heart rate between 60 and 90 beats per minute with normal sinus rhythm
- Respiratory rate less than 14 breaths per minute
- Resting diastolic blood pressure between 60 and 90 mm Hg and systolic blood pressure between 110 and 140 mm Hg
- Peripheral blood oxygen saturation above 95%
- Up-to-date immunizations as assessed by primary care physician
- Negative urine pregnancy test within 7 days before first dose for women of childbearing potential
- Agreement to use two effective contraceptive methods during the study and for 90 days after for sexually active women of childbearing potential and male subjects
- Willingness to comply with all study requirements
- Adequate cognitive function to understand and sign informed consent before screening
You will not qualify if you...
- Body mass index over 30
- Flu-like syndrome or respiratory infection within 2 weeks before screening
- Active COVID-19 disease
- Pregnant, breastfeeding, lactating, or planning pregnancy during study
- Positive pregnancy test at screening or on dosing day for females of childbearing potential
- Unstable or medically unmanaged acute or chronic disease
- History of bradycardia, cardiovascular dysrhythmias, or use of beta blockers
- Cardiopulmonary diseases including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, or obstructive sleep apnea requiring CPAP
- Bowel obstruction, pneumocephalus, or other conditions causing air pockets that may expand after xenon administration
- Conditions or medications causing delayed gastric emptying
- Known or potential difficult airway
- Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes
- Use of corticosteroids within 1 month before first treatment
- History of cancer within past 5 years except treated basal cell carcinoma
- Any other clinically significant condition or abnormal lab results interfering with study participation
- History of alcohol or substance abuse within past 2 years
- Clinically significant lab abnormalities at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here