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Tests treatment safety and results for Healthy Volunteer Study
Official title Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
ClinicalTrials.gov ID: NCT06945614
What this study is testing
What is Xenon gas inhalation?
Xenon gas inhalation is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for healthy volunteer study.
Also referred to as Inhalation of xenon gas.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Study people 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
You likely can't join 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.
See the full eligibility criteria
- Study people 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...
- 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.
- 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.
- History of cancer in the past 5 years, with the exception of successfully treated basal cell carcinoma.
- 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...
- History of alcohol or substance abuse or dependence within the past 2 years.
- Clinically significant abnormalities in screening laboratories.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.