Healthy Volunteer StudyPhase 1NCT06945614
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
A Phase 1 study testing Xenon gas inhalation in people with Healthy Volunteer Study, run by General Biophysics LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Xenon gas inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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 with participation in this study.
- History of alcohol or substance abuse or dependence within the past 2 years.
- Clinically significant abnormalities in screening laboratories.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Laura Mazuera, 617-732-6573, xenon@mgb.org
Howard L Weiner, MD
About this study
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
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.
Read the detailed description
The investigators plan to find out if xenon gas can help people with Alzheimer's disease, but it needs to be studied in healthy volunteers first. This study will show if xenon gas is safe to take without causing too many side effects. Xenon gas is not approved by the U.S. Food and Drug Administration (FDA). This means that the use of xenon gas is investigational and can only be used in research studies.
This single-center, open-label study will evaluate the safety and efficacy of xenon gas inhalation for 4 different durations of administration in healthy subjects. The study will be conducted at a single investigational site, with 4 dosing cohorts of 4 subjects each; xenon gas via inhalation for 10, 20, 30, and 45 minutes. Assignment into the study treatment groups occurs sequentially and participants will be informed which group they are in during the screening visit. This study will enroll healthy individuals who meet eligibility criteria. The maximum planned study duration for each subject is 15 days. This includes a screening period of up to 7 days during which eligibility is determined, and post-treatment observation on Days 1, 3 and 7 for follow-up safety monitoring.
Subjects will be screened and enrolled at the Center for Alzheimer Research and Treatment (CART). Initial treatment visits will occur in the Center for Clinical Investigation (CCI) with follow-up visits occurring in CART. Both centers are in the Building for Transformative Medicine, Brigham and Women's Hospital (BWH) at 60 Fenwood Road, Boston, MA 02115.
Participants will undergo screening procedures including hematology, clinical chemistry, vital signs, electrocardiogram (ECG), and a complete physical exam by the physician investigator or a mid-level practitioner. Each subject must have normal laboratory tests, or results must be in a clinically acceptable range in the opinion of the Investigator. Participants meeting eligibility criteria and completing screening activities will be assigned to a dosing group, based on the order of their enrollment after screening.
The dosing visit will occur the following week on a Monday or Tuesday. Participant's vital signs will be measured before study treatment administration, and on an ongoing basis throughout study treatment until discharged. Participant will also receive a dose of Zofran® prior to the administration of xenon gas to prevent any of the negative side effects that may occur. Xenon gas will be administered through machine providing gas inhalation (breathing in) under the supervision of a study anesthesiologist. An anesthesia face mask will be used to deliver the inhalation gas. The flow of xenon gas and oxygen will be controlled manually by the study anesthesiologist during the study treatment. The gas concentrations will be controlled and monitored by the study anesthesiologist. The monitors for blood pressure, pulse oximetry (measures blood oxygen), and electrocardiography (measures heart activity) will be attached to participant during the inhalation study treatment procedure. Participants will receive xenon gas inhalation for 10, 20, 30, or 45 minutes. After xenon gas inhalation, pure oxygen will be supplied for five minutes. The total procedure will take approximately 20 minutes longer than the specified administration period. Following dosing, participants will be monitored for at least 2 hours before being discharged. Additional blood sample and vitals will be obtained during monitoring.
Participants will make 3 additional visits; 1 day, 3 days, and 7 days following xenon gas administration. At each follow up visit, participants will undergo procedures including hematology, clinical chemistry, vital signs, ECG, and a complete physical exam by the physician investigator or a mid-level practitioner. Each subject must have normal laboratory tests, or results must be in a clinically acceptable range in the opinion of the Investigator. Blood samples for immunologic analysis will be obtained at every visit. Visit 5, or 7 days following xenon gas administration will be the final visit. After participants complete the study, they will be referred back to their own doctors for ongoing medical care.
- Conditions
- Healthy Volunteer Study
- Being tested
- Xenon gas inhalation
- Keywords
- Xenon gas, inhalation, Alzheimer's disease, neurodegenerative, Healthy volunteer
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon gas inhalationDrug
Also called Inhalation of xenon gas
Administration of xenon gas in the mixture with oxygen for the period of time via inhalation
| Study group | Role | What they receive |
|---|---|---|
| 10 minute inhalation | Experimental | Xenon gas inhalation administered for 10 minutes Receives: Drug: Xenon gas inhalation |
| 20 minute inhalation | Experimental | Xenon gas inhalation administered for 20 minutes Receives: Drug: Xenon gas inhalation |
| 30 minute inhalation | Experimental | Xenon gas inhalation administered for 30 minutes Receives: Drug: Xenon gas inhalation |
| 45 minute inhalation | Experimental | Xenon gas inhalation administered for 45 minutes Receives: Drug: Xenon gas inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Depending on the duration of the xenon inhalation treatment and time after the treatment (immediately, 1 day, 3 days, and 7 days) the blood biomarkers will be measured. We anticipate to see the effect of xenon inhalation on immune cells as well as cytokines and hormones panels for the plasma samples. Specifically, the change from the baseline in the number and phenotypes of blood monocytes, Natural Killer Cells (NK), B cells, CD4, CD8 T cells and neutrophils will be measured. In addition the change from the baseline in cytokines and hormone levels in the plasma samples will be measured.
Measured: From treatment to the end of follow up in 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start16 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Biophysics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ilya Ilin, PhD, Principal investigator, General BiophysicsHoward L Weiner, MD, Principal investigator, Brigham and Women"s Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945614
- Sponsor's protocol ID
- Pro00082384
- Other IDs
- R42AG073059, HLW-ALZ-Xen-001
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39813317
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06945614
- Acronym / sponsor ID
- Pro00082384
- Conditions
- Healthy Volunteer Study
- Keywords
- Xenon gas, inhalation, Alzheimer's disease, neurodegenerative, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- General Biophysics LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators plan to find out if xenon gas can help people with Alzheimer's disease, but it needs to be studied in healthy volunteers first. This study will show if xenon gas is safe to take without causing too many side effects. Xenon gas is not approved by the U.S. Food and Drug Administration (FDA). This means that the use of xenon gas is investigational and can only be used in research studies.
This single-center, open-label study will evaluate the safety and efficacy of xenon gas inhalation for 4 different durations of administration in healthy subjects. The study will be conducted at a single investigational site, with 4 dosing cohorts of 4 subjects each; xenon gas via inhalation for 10, 20, 30, and 45 minutes. Assignment into the study treatment groups occurs sequentially and participants will be informed which group they are in during the screening visit. This study will enroll healthy individuals who meet eligibility criteria. The maximum planned study duration for each subject is 15 days. This includes a screening period of up to 7 days during which eligibility is determined, and post-treatment observation on Days 1, 3 and 7 for follow-up safety monitoring.
Subjects will be screened and enrolled at the Center for Alzheimer Research and Treatment (CART). Initial treatment visits will occur in the Center for Clinical Investigation (CCI) with follow-up visits occurring in CART. Both centers are in the Building for Transformative Medicine, Brigham and Women's Hospital (BWH) at 60 Fenwood Road, Boston, MA 02115.
Participants will undergo screening procedures including hematology, clinical chemistry, vital signs, electrocardiogram (ECG), and a complete physical exam by the physician investigator or a mid-level practitioner. Each subject must have normal laboratory tests, or results must be in a clinically acceptable range in the opinion of the Investigator. Participants meeting eligibility criteria and completing screening activities will be assigned to a dosing group, based on the order of their enrollment after screening.
The dosing visit will occur the following week on a Monday or Tuesday. Participant's vital signs will be measured before study treatment administration, and on an ongoing basis throughout study treatment until discharged. Participant will also receive a dose of Zofran® prior to the administration of xenon gas to prevent any of the negative side effects that may occur. Xenon gas will be administered through machine providing gas inhalation (breathing in) under the supervision of a study anesthesiologist. An anesthesia face mask will be used to deliver the inhalation gas. The flow of xenon gas and oxygen will be controlled manually by the study anesthesiologist during the study treatment. The gas concentrations will be controlled and monitored by the study anesthesiologist. The monitors for blood pressure, pulse oximetry (measures blood oxygen), and electrocardiography (measures heart activity) will be attached to participant during the inhalation study treatment procedure. Participants will receive xenon gas inhalation for 10, 20, 30, or 45 minutes. After xenon gas inhalation, pure oxygen will be supplied for five minutes. The total procedure will take approximately 20 minutes longer than the specified administration period. Following dosing, participants will be monitored for at least 2 hours before being discharged. Additional blood sample and vitals will be obtained during monitoring.
Participants will make 3 additional visits; 1 day, 3 days, and 7 days following xenon gas administration. At each follow up visit, participants will undergo procedures including hematology, clinical chemistry, vital signs, ECG, and a complete physical exam by the physician investigator or a mid-level practitioner. Each subject must have normal laboratory tests, or results must be in a clinically acceptable range in the opinion of the Investigator. Blood samples for immunologic analysis will be obtained at every visit. Visit 5, or 7 days following xenon gas administration will be the final visit. After participants complete the study, they will be referred back to their own doctors for ongoing medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 minute inhalation | Experimental | Drug: Xenon gas inhalationXenon gas inhalation administered for 10 minutes |
| 20 minute inhalation | Experimental | Drug: Xenon gas inhalationXenon gas inhalation administered for 20 minutes |
| 30 minute inhalation | Experimental | Drug: Xenon gas inhalationXenon gas inhalation administered for 30 minutes |
| 45 minute inhalation | Experimental | Drug: Xenon gas inhalationXenon gas inhalation administered for 45 minutes |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Immunizations fully up to date at Screening, according to the assessment of their primary care physician.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon gas inhalationAlso: Inhalation of xenon gasAdministration of xenon gas in the mixture with oxygen for the period of time via inhalation | Drug | 10 minute inhalation, 20 minute inhalation, 30 minute inhalation, 45 minute inhalation |
Primary outcome
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
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.
1 secondary outcome
Number of Participants With Treatment Related Change in Blood Biomarkers From the Baseline.
Time frame: From treatment to the end of follow up in 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 39813317Brandao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilya Ilin, PhD principal investigator
General Biophysics
Howard L Weiner, MD principal investigator
Brigham and Women"s Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xenon gas inhalation in people with Healthy Volunteer Study, run by General Biophysics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.