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

NCT06945614 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: Pro00082384R42AG073059HLW-ALZ-Xen-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer Study

Keywords

Xenon gas; inhalation; Alzheimer's disease; neurodegenerative; Healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Xenon Treatment-Related Adverse Events at Each Treatment Duration as Assessed by CTCAE v4.0

  To determine the safety of xenon gas inhalation for 10, 20, 30, and 45 minutes in healthy volunteers. Investigators anticipate to observe no sedation, no nausea, and no vomiting. Measured Parameters for Safety Assessments during Xenon Administration (Intraoperative - every five (5) minutes): * Heart rate * Blood pressure * Respiratory rate * Body temperature * Peripheral blood oxygenation * Changes in capnometry * Electrocardiographic parameters and printed rhythm strip * Adverse events Depth of sedation will be assessed and recorded every five (5) minutes during Xenon Gas administration and upon completion of procedure and recovery, utilizing the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) by the anesthesiologist. Adverse events of special interest for this inhaled anesthetic: vomiting, hemodynamic changes requiring drug intervention, and sedation unresponsive to verbal commands. AEs will be assessed during repeated visits on day 1, day 3, and day 7.

  From treatment to the end of follow up at 7 days

Secondary Outcomes (1)

• Number of Participants With Treatment Related Change in Blood Biomarkers From the Baseline.

  From treatment to the end of follow up in 7 days

Study Arms (4)

10 minute inhalation

EXPERIMENTAL

Xenon gas inhalation administered for 10 minutes

Drug: Xenon gas inhalation

20 minute inhalation

EXPERIMENTAL

Xenon gas inhalation administered for 20 minutes

Drug: Xenon gas inhalation

30 minute inhalation

EXPERIMENTAL

Xenon gas inhalation administered for 30 minutes

Drug: Xenon gas inhalation

45 minute inhalation

EXPERIMENTAL

Xenon gas inhalation administered for 45 minutes

Drug: Xenon gas inhalation

Interventions

Xenon gas inhalation DRUG

Administration of xenon gas in the mixture with oxygen for the period of time via inhalation

Also known as: Inhalation of xenon gas

10 minute inhalation; 20 minute inhalation; 30 minute inhalation; 45 minute inhalation

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects must meet the following eligibility criteria to participate in the study.
• Male or female, aged 55-75 years.
• Good general health with no disease likely to interfere with the study assessments.
• Baseline vital signs within the following ranges:
• resting heart rate 60 to 90 BPM with Normal Sinus Rhythm
• respiratory rate less than 14
• 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
• Peripheral blood oxygen saturation \>95%
• Immunizations fully up to date at Screening, according to the assessment of their primary care physician.
• 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.
• Willingness to comply with all study requirements.
• Adequate cognitive function to understand and sign the IRB-approved ICF before any protocol-specific screening procedures are performed.

You may not qualify if:

• Individuals who meet any of the following criteria at Screening will be excluded from the study:
• 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.
• Females of childbearing potential will undergo a pregnancy test at Screening and be excluded from the study if positive.
• A urine pregnancy test will also be performed on the morning of the dosing day.
• History of a clinically significant acute or chronic disease that is not stable and medically managed in the judgment of the study physician.
• History of bradycardia or other cardiovascular dysrhythmias or who are receiving beta blockers.
• Cardiopulmonary disease, including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, obstructive sleep apnea requiring CPAP.
• Bowel obstruction, pneumocephalus, or other diseases with the potential for an air pocket and expansion following xenon administration.
• Any medical condition or receiving any medications that predispose to delayed gastric emptying.
• Known difficult airway, or potential for a difficult airway based on a thorough airway exam by an anesthesiologist.
• Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes.
• Use of corticosteroids within the past month prior to the first treatment.

Sponsors & Collaborators

• General Biophysics LLC: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Brandao W, Jain N, Yin Z, Kleemann KL, Carpenter M, Bao X, Serrano JR, Tycksen E, Durao A, Barry JL, Baufeld C, Guneykaya D, Zhang X, Litvinchuk A, Jiang H, Rosenzweig N, Pitts KM, Aronchik M, Yahya T, Cao T, Takahashi MK, Krishnan R, Davtyan H, Ulrich JD, Blurton-Jones M, Ilin I, Weiner HL, Holtzman DM, Butovsky O. Inhaled xenon modulates microglia and ameliorates disease in mouse models of amyloidosis and tauopathy. Sci Transl Med. 2025 Jan 15;17(781):eadk3690. doi: 10.1126/scitranslmed.adk3690. Epub 2025 Jan 15.

  PMID: 39813317 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilya Ilin, PhD

  General Biophysics

  PRINCIPAL INVESTIGATOR

• Howard L Weiner, MD

  Brigham and Women"s Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 25, 2025
• Study Start: April 16, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)