Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-18 @ 9:58 AM
Study NCT ID:
NCT06945614
Status:
None
Last Update Posted:
2025-04-25 00:00:00
First Post:
2025-04-09 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: