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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age55-75
SponsorGeneral Biophysics LLC

About 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.

Eligibility criteria

Qualifiers

Male or female, aged 55-75 years.

Good general health with no disease likely to interfere with the study assessments.

resting heart rate 60 to 90 BPM with Normal Sinus Rhythm

respiratory rate less than 14

Disqualifiers

Body mass index >30.

Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.

Active SARS-CoV-2 (COVID-19) disease.

A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.

Trial design

Treatments tested in this trial

  • Xenon gas inhalation

Treatment groups

16 Participants
are divided into 4 treatment groups

Sponsors and collaborators

General Biophysics LLC

Lead sponsor

National Institute on Aging (NIA)

Collaborator