Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
General Biophysics LLC
Study ID
NCT06945614
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer Study

Eligibility Criteria

Sex
ALL
Age
55 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Xenon gas inhalation — DRUG
    Administration of xenon gas in the mixture with oxygen for the period of time via inhalation

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 10 minute inhalation
    Xenon gas inhalation administered for 10 minutes
  • Experimental: 20 minute inhalation
    Xenon gas inhalation administered for 20 minutes
  • Experimental: 30 minute inhalation
    Xenon gas inhalation administered for 30 minutes
  • Experimental: 45 minute inhalation
    Xenon gas inhalation administered for 45 minutes

Primary Outcome Measure

Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0 [ Time Frame: From treatment to the end of follow up at 7 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Laura Mazuera
[email protected]
617-732-6573
Howard L Weiner, MD (PRINCIPAL_INVESTIGATOR)
Chris Connor, MD (SUB_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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