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

Trial Summary

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.

How does Xenon Gas Inhalation treatment differ from other treatments for neuroinflammatory disease?

Xenon Gas Inhalation is unique because it involves inhaling a gas, which is a non-invasive method, unlike many traditional treatments that may require oral or injectable medications. This treatment may offer a novel approach by potentially targeting neuroinflammation directly through the respiratory system, which is different from conventional therapies that often focus on systemic administration. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Ilya Ilin, PhD

Principal Investigator

General Biophysics

Howard L Weiner, MD

Principal Investigator

Brigham and Women"s Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Nuclear imaging of inflammation in neurologic and psychiatric disorders. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A Model of Systemic Inflammation to Study Neuroinflammation. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of neuroinflammation on the cerebral metabolism at baseline and after neural stimulation in neurodegenerative diseases. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In Vivo Imaging of Human Neuroinflammation. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Molecular imaging of neuroinflammation in preclinical rodent models using positron emission tomography. [2017]