RECRUITING

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

Conditions

Healthy Volunteer Study Xenon gas inhalation Alzheimer's disease neurodegenerative Healthy volunteer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Proof-of-Concept, Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation in Healthy Human Subjects

Quick Facts

Study Start:2025-04-16

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06945614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, aged 55-75 years. 2. Good general health with no disease likely to interfere with the study assessments. 3. Baseline vital signs within the following ranges: 1. resting heart rate 60 to 90 BPM with Normal Sinus Rhythm 2. respiratory rate less than 14 3. 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 4. Peripheral blood oxygen saturation \>95% 4. Immunizations fully up to date at Screening, according to the assessment of their primary care physician. 5. 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. 6. Willingness to comply with all study requirements. 7. Adequate cognitive function to understand and sign the IRB-approved ICF before any protocol-specific screening procedures are performed.	1. Body mass index \>30. 2. Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit. 3. Active SARS-CoV-2 (COVID-19) disease. 4. A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study. 1. Females of childbearing potential will undergo a pregnancy test at Screening and be excluded from the study if positive. 2. A urine pregnancy test will also be performed on the morning of the dosing day. 5. History of a clinically significant acute or chronic disease that is not stable and medically managed in the judgment of the study physician. 6. History of bradycardia or other cardiovascular dysrhythmias or who are receiving beta blockers. 7. Cardiopulmonary disease, including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, obstructive sleep apnea requiring CPAP. 8. Bowel obstruction, pneumocephalus, or other diseases with the potential for an air pocket and expansion following xenon administration. 9. Any medical condition or receiving any medications that predispose to delayed gastric emptying. 10. Known difficult airway, or potential for a difficult airway based on a thorough airway exam by an anesthesiologist. 11. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes. 12. Use of corticosteroids within the past month prior to the first treatment. 13. History of cancer in the past 5 years, with the exception of successfully treated basal cell carcinoma. 14. Any other clinically significant medical condition or illness as determined by medical history, clinical laboratory results, or other screening safety tests that, in the judgment of the Investigator, would interfere with participation in this study. 15. History of alcohol or substance abuse or dependence within the past 2 years. 16. Clinically significant abnormalities in screening laboratories.

Inclusion Criteria

Exclusion Criteria

1. Male or female, aged 55-75 years.
2. Good general health with no disease likely to interfere with the study assessments.
3. Baseline vital signs within the following ranges:
1. resting heart rate 60 to 90 BPM with Normal Sinus Rhythm
2. respiratory rate less than 14
3. 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
4. Peripheral blood oxygen saturation \>95%
4. Immunizations fully up to date at Screening, according to the assessment of their primary care physician.
5. 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.
6. Willingness to comply with all study requirements.
7. Adequate cognitive function to understand and sign the IRB-approved ICF before any protocol-specific screening procedures are performed.

1. Body mass index \>30.
2. Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening visit.
3. Active SARS-CoV-2 (COVID-19) disease.
4. A female who is pregnant, lactating, breastfeeding, or planning on becoming pregnant during study.
1. Females of childbearing potential will undergo a pregnancy test at Screening and be excluded from the study if positive.
2. A urine pregnancy test will also be performed on the morning of the dosing day.
5. History of a clinically significant acute or chronic disease that is not stable and medically managed in the judgment of the study physician.
6. History of bradycardia or other cardiovascular dysrhythmias or who are receiving beta blockers.
7. Cardiopulmonary disease, including pulmonary fibrosis, COPD, altered pulmonary function, lung injury, pulmonary hypertension, obstructive sleep apnea requiring CPAP.
8. Bowel obstruction, pneumocephalus, or other diseases with the potential for an air pocket and expansion following xenon administration.
9. Any medical condition or receiving any medications that predispose to delayed gastric emptying.
10. Known difficult airway, or potential for a difficult airway based on a thorough airway exam by an anesthesiologist.
11. Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, asthma, thyroid disease, or type 1 diabetes.
12. Use of corticosteroids within the past month prior to the first treatment.
13. History of cancer in the past 5 years, with the exception of successfully treated basal cell carcinoma.
14. Any other clinically significant medical condition or illness as determined by medical history, clinical laboratory results, or other screening safety tests that, in the judgment of the Investigator, would interfere with participation in this study.
15. History of alcohol or substance abuse or dependence within the past 2 years.
16. Clinically significant abnormalities in screening laboratories.

Contacts and Locations

Principal Investigator

Ilya Ilin, PhD

PRINCIPAL_INVESTIGATOR

General Biophysics

Howard L Weiner, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women"s Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: General Biophysics LLC

Ilya Ilin, PhD, PRINCIPAL_INVESTIGATOR, General Biophysics
Howard L Weiner, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women"s Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-04-16

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Xenon gas
inhalation
Alzheimer's disease
neurodegenerative
Healthy volunteer

Additional Relevant MeSH Terms

Healthy Volunteer Study