Assessing the safety of inhaling xenon gas in healthy volunteers

A Proof-of-Concept, Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation in Healthy Human Subjects

This study is testing if inhaling xenon gas is safe for healthy people to see if it could help in treating neurodegenerative diseases like Alzheimer's in the future.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: General Biophysics LLC (Industry-sponsored)
• Drugs / interventions: CART
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06945614 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and efficacy of xenon gas inhalation in healthy volunteers as a precursor to potential treatment for neurodegenerative diseases like Alzheimer's. Participants will be administered xenon gas in low concentrations via an anesthetic machine, with their vital signs monitored and blood samples collected throughout the study. The study involves four treatment groups, each receiving different durations of xenon gas inhalation, and will take place over approximately 14 days with five visits. The goal is to ensure that xenon gas does not cause significant side effects before further studies in patients with Alzheimer's disease.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 55-75 years with no significant health issues.

Not a fit: Patients with existing health conditions that could interfere with the study assessments will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could pave the way for new therapeutic approaches to manage neuroinflammation in Alzheimer's disease.

How similar studies have performed: While xenon gas is investigational and not yet approved, similar studies exploring its effects on neuroinflammation have shown promise, though this specific approach is novel.

Eligibility criteria

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. Immunizations fully up to date at Screening, according to the assessment of their primary care physician.
5. Negative urine pregnancy test within 7 days prior to the first dose of investigational product for women of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses any time in the preceding 24 consecutive months). Sexually active women of childbearing potential and male subjects must agree to use two effective contraceptive methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 90 days after the completion of study treatment. Contraceptive methods will be documented with other concomitant medications.
6. Willingness to comply with all study requirements.
7. Adequate cognitive function to understand and sign the IRB-approved ICF before any protocol-specific screening procedures are performed.

Exclusion Criteria:

Individuals who meet any of the following criteria at Screening will be excluded from the study:

1. Body mass index \>30.
2. Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.
3. Active SARS-CoV-2 (COVID-19) disease.
4. A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.

   1. Females of childbearing potential will undergo a pregnancy test at Screening and be excluded from the study if positive.
   2. A urine pregnancy test will also be performed on the morning of the dosing day.
5. History of a clinically significant acute or chronic disease that is not stable and medically managed in the judgment of the study physician.
6. History of bradycardia or other cardiovascular dysrhythmias or who are receiving beta blockers.
7. Cardiopulmonary disease, including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, obstructive sleep apnea requiring CPAP.
8. Bowel obstruction, pneumocephalus, or other diseases with the potential for an air pocket and expansion following xenon administration.
9. Any medical condition or receiving any medications that predispose to delayed gastric emptying.
10. Known difficult airway, or potential for a difficult airway based on a thorough airway exam by an anesthesiologist.
11. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes.
12. Use of corticosteroids within the past month prior to the first treatment.
13. History of cancer in the past 5 years, with the exception of successfully treated basal cell carcinoma.
14. Any other clinically significant medical condition or illness as determined by medical history, clinical laboratory results, or other screening safety tests that, in the judgment of the Investigator, would interfere with participation in this study.
15. History of alcohol or substance abuse or dependence within the past 2 years.
16. Clinically significant abnormalities in screening laboratories.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Ilya Ilin, PhD — General Biophysics

Conditions Healthy Volunteer Study; Xenon gas; inhalation; Alzheimer' s disease; neurodegenerative; Healthy volunteer