Xenon Gas Inhalation for Neuroinflammatory Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: General Biophysics LLC

Must not be taking: Beta blockers, Corticosteroids

Disqualifiers: Obesity, Respiratory infections, Cardiopulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of inhaling xenon gas as a potential treatment for diseases like Alzheimer's. Participants will inhale the gas for varying durations to determine any side effects. The trial seeks healthy individuals without major health issues who can commit to several visits over two weeks. Those who are generally healthy and have no breathing problems might be a good fit. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using corticosteroids or have certain medical conditions. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inhaling xenon gas offers potential benefits, as demonstrated in animal studies. It reduced brain swelling, prevented brain shrinkage, and supported brain health in mice, suggesting possible benefits for humans.

Regarding human safety, limited information exists because this treatment remains in early testing stages. This trial primarily aims to assess safety in healthy individuals. As it is the first phase, researchers are monitoring for side effects and evaluating how well participants tolerate the treatment. The results will determine if xenon gas inhalation is safe for further studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for neuroinflammatory diseases focus on reducing inflammation through medications like corticosteroids or immunosuppressants. However, Xenon gas inhalation works differently by leveraging the unique properties of xenon gas, which is known for its neuroprotective effects. Researchers are excited because xenon gas potentially targets the inflammation at a cellular level by modulating neurotransmitter receptors, offering a novel mechanism of action. Additionally, it is administered through inhalation, which could provide a faster and more direct delivery compared to traditional oral or injectable medications. This approach could potentially lead to quicker symptom relief and fewer systemic side effects.

What evidence suggests that this trial's treatments could be effective for neurodegenerative diseases?

Research has shown that inhaling xenon gas offers potential benefits based on early studies. Tests with mice demonstrated that xenon inhalation reduced brain inflammation and protected against damage related to Alzheimer's disease. It also decreased brain shrinkage and supported the growth of healthy brain cells. Additionally, xenon improved recovery after brain injuries by protecting the brain. These findings suggest that xenon might help treat diseases that cause brain damage by reducing harmful inflammation. In this trial, participants will inhale xenon gas for varying durations—10, 20, 30, or 45 minutes—to evaluate its effects on neuroinflammatory diseases. ^{1 3 6 7 8}

Who Is on the Research Team?

Howard L Weiner, MD

Principal Investigator

Brigham and Women"s Hospital

Ilya Ilin, PhD

Principal Investigator

General Biophysics

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who are interested in helping to assess the safety of Xenon gas inhalation, which may be used as a therapy for neurodegenerative diseases. Specific eligibility criteria details were not provided.

Inclusion Criteria

Baseline vital signs within specified ranges

Immunizations fully up to date at Screening

Negative urine pregnancy test within 7 days prior to the first dose of investigational product for women of childbearing potential

Exclusion Criteria

I haven't had flu or respiratory infections in the last 2 weeks.

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

I have a history of specific acute or chronic diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 7 days

1 visit (in-person)

Treatment

Participants receive xenon gas inhalation for 10, 20, 30, or 45 minutes under supervision, with monitoring of vital signs and administration of Zofran® to prevent side effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples and vitals collected at each visit

7 days

3 visits (in-person) on Days 1, 3, and 7

What Are the Treatments Tested in This Trial?

Interventions

• Xenon Gas Inhalation

Trial Overview The study tests the safety of inhaling Xenon gas at low concentrations using an anesthesia machine. Participants will be divided into four groups based on treatment duration and monitored over five visits within approximately two weeks.

How Is the Trial Designed?

Group I: 45 minute inhalation Experimental Treatment 1 Intervention

Xenon gas inhalation administered for 45 minutes

Group II: 30 minute inhalation Experimental Treatment 1 Intervention

Xenon gas inhalation administered for 30 minutes

Group III: 20 minute inhalation Experimental Treatment 1 Intervention

Xenon gas inhalation administered for 20 minutes

Group IV: 10 minute inhalation Experimental Treatment 1 Intervention

Xenon gas inhalation administered for 10 minutes

Who Is Running the Clinical Trial?

General Biophysics LLC

Lead Sponsor

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6676773/

Xenon improves long-term cognitive function, reduces ... Xenon is a noble gas with neuroprotective properties that can improve short and long-term outcomes in young adult mice after controlled cortical impact.

2. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/study-on-xenon-gas-protecting-against-alzheimers-disease-leads-to-clinical-trial

Study Finding Xenon Gas Could Protect Against ... The study found that Xenon gas inhalation suppressed neuroinflammation, reduced brain atrophy, and increased protective neuronal states in mouse models of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06945614?aggFilters=status:rec,healthy:y&country=United%20States&state=Massachusetts&city=Boston&locStr=Boston,%20Massachusetts,%20United%20States&lastUpdPost=2019-07-04_&viewType=Table&rank=10

Exploratory Clinical Study to Assess Safety and Efficacy of ... 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 ...

4. news-medical.net news-medical.net/news/20250116/Xenon-gas-offers-potential-neuroprotective-effects-for-Alzheimers-patients.aspx

Xenon gas offers potential neuroprotective effects for ... The study found that Xenon gas inhalation suppressed neuroinflammation, reduced brain atrophy, and increased protective neuronal states in mouse models of ...

5. science.org science.org/doi/10.1126/scitranslmed.adk3690

Inhaled xenon modulates microglia and ameliorates ... Xe inhalation induced microglial phagocytosis and reduced amyloidosis, neuritic dystrophy, and inflammation while promoting a protective microglial phenotype.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10280919/

Effect of xenon on brain injury, neurological outcome, and ... The primary objective of the study is to explore the potential neuroprotective effects of inhaled xenon, when administered within 6 h after the ...

7. trialx.com trialx.com/clinical-trials/listings/296904/exploratory-clinical-study-to-assess-safety-and-efficacy-of-xenon-gas-inhalation-to-control-neuroinflammation/?&radius=50

Exploratory Clinical Study to Assess Safety and Efficacy of ... The goal of this clinical study is to evaluate safety of Xenon gas inhalation in healthy volunteers. This first phase safety clinical study is ...

8. withpower.com withpower.com/trial/phase-1-respiratory-aspiration-3-2025-14190

Xenon Gas Inhalation for Neuroinflammatory Disease 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 ...