Decompression SicknessPhase 2NCT06216366
Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
A Phase 2 study testing Sodium Chloride 0.9% Inj pre-exposure, Sodium Chloride 0.9% Inj post-exposure and Recombinant human plasma gelsolin pre-exposure in people with Decompression Sickness, run by BioAegis Therapeutics Inc. at 1 site in United States.
Trial summary
Healthy trained SCUBA divers will be randomized into three groups and exposed to a high-pressure profile in a hyperbaric chamber. The high-pressure profile simulates the pressure at a depth of 30 meters of sea water (MSW) for 35 minutes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decompression Sickness
- What is being tested?
- Sodium Chloride 0.9% Inj pre-exposure, Sodium Chloride 0.9% Inj post-exposure and Recombinant human plasma gelsolin pre-exposure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experienced healthy trained female or male SCUBA divers without known underlying comorbidities
- Age ≥18
- Informed consent obtained from subject
- During the course of the study starting at screening and for at least 3 months after their final study treatment:
- Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods
- Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner
- All subjects must agree not to donate sperm or eggs
Who cannot join
- Any co-morbidity contraindicating SCUBA diving
- Pregnant or lactating women
- History of unrepaired cardiac shunt or echocardiographic evidence of patent foramen ovale or atrial septal defect
- Any active underlying conditions including but not limited to cancer or other illness treated with systemic chemotherapy, immunomodulatory biologics, or radiation therapy during the last 360 days or expected to be treated in the upcoming 120 days
- Refusal or inability to use adequate contraception
- Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
Show all 11Show fewer
- Any acute illness or vaccination in the previous 30 days
- History of alcohol or recreation drug use disorder
- Known allergy to study drug or excipients
- Weight >125 kg
- Unsuitable for study participation, in the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Official title: Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety/Tolerability of IV Rhu-pGSN as a Pre- or Post-Exposure Intervention to Mitigate Proinflammatory Responses to Decompression After High Pressure in a Hyperbaric Chamber
Healthy trained SCUBA divers will be randomized into three groups and exposed to a high-pressure profile in a hyperbaric chamber. The high-pressure profile simulates the pressure at a depth of 30 meters of sea water (MSW) for 35 minutes. In the control group, the subjects will receive intravenous normal saline immediately before and after the high-pressure exposure. The second group will receive intravenous recombinant human gelsolin (rhu-pGSN) 24 mg/kg immediately prior to the exposure, and saline post-exposure. The third group will receive saline pre-exposure and rhu-pGSN post-exposure. Blood samples will be collected at multiple time points pre- and post-exposure to assess levels of inflammatory markers, including interleukin (IL)-1β. Other assessments include screening for gas bubbles, a validated questionnaire to assess the incidence of clinical decompression sickness (DCS), measurement of plasma gelsolin (pGSN) levels, and measurement of anti-pGSN antibodies.
Read the detailed description
This is a prospective, randomized, double-blind, placebo-controlled study in healthy volunteers who have been trained for SCUBA diving.
The study will be performed in the hyperbaric chamber at the University of Maryland. Healthy trained divers will be exposed to a high-pressure profile known to cause decreased plasma gelsolin (pGSN), increased microparticles (MPs), and cytokine changes with no adverse effects such as decompression sickness (DCS). The intervention with recombinant human plasma gelsolin (rhu-pGSN) is patterned after the animal model of DCS where rhu-pGSN administration prior to or after decompression abrogated organ injuries concurrent with inhibiting elevations of MPs and intra-particle interleukin (IL)-1β concentration.
There will be three experimental groups. The control subjects will receive intravenous sterile 0.9% saline immediately before and immediately after the 35-minute 30 meters of sea water (MSW) exposure. A second group will receive intravenous rhu-pGSN 24 mg/kg immediately prior to the high pressure exposure and sterile saline post-exposure. The third group will receive sterile saline prior to the exposure and 24 mg/kg rhu-pGSN post-exposure. Development of DCS is not anticipated based on previous experience with 30 MSW exposure for 35 minutes.
Once informed consent is obtained, the following assessments/procedures will be performed:
- Confirm the potential participant is healthy and has been trained as a SCUBA diver.
- Record medical history, including concomitant medications.
- Perform pregnancy test (urine or blood) for women of childbearing potential.
- Perform vital signs and physical examination.
- Perform EKG.
- Measure CBC and metabolic profile lab tests at local laboratory.
- Collect pretreatment blood samples for measurement of pGSN and analysis of antibodies against pGSN.
- Perform Cardiac Echo for bubbles.
- Collect aliquots of blood for subsequent biomarker assays (including IL-1β, pGSN, nitric oxide synthase [NOS2], tumor necrosis factor [TNF]) and microparticles for analysis.
- If eligibility criteria are satisfied, the subject will be randomized 1:1:1 (rhu-pGSN pre high pressure exposure:rhu-pGSN post high pressure exposure:saline placebo). After reconstitution to 200 mg in a final volume of 5 mL in a 10-mL vial, rhu pGSN is not to be kept at room temperature for >2 hours prior to beginning the IV push. Study drug is administered by an IV push through a 0.2 μm filter. The syringe, filter, and extension tubing for the IV push of study drug are to be connected as close to the subjects as possible. Each subject will receive 2 IV study injections. No subject will receive more than 1 dose of rhu-pGSN.
- Subject will be exposed to high pressure (30 meters salt water [MSW] for 35 minutes) and followed up for 24 hours and again at day 14.
- A well-being questionnaire will be administered.
Before the 30 MSW exposure, blood will be obtained from all subjects for pre-exposure measurements. A second sampling will be obtained after 30 minutes post initiation of the exposure to high pressure while still at pressure in the hyperbaric chamber and before decompression to assess whether inflammatory changes occurring due to pressure and before decompression are altered by rhu-pGSN when administered pre-exposure to high pressure. Blood specimens will be obtained at 60, 120 and 240 minutes after decompression.
Prior to, and following the 30 MSW exposure, all subjects will be screened for gas bubbles (vascular gas emboli [VGE]) using a phase array ultrasonic probe. Intravascular bubbles are thought to play a role in the evolution of DCS. Preliminary work has demonstrated that rhu-pGSN can lyse inflammatory MPs and ~28% of MPs contain a gas phase of nitrogen dioxide that can serve as a nucleation site for bubble formation. Therefore, this work will also evaluate whether rhu-pGSN can prevent bubble production.
The Doolette well-being questionnaire will be administered 60 minutes after decompression.
On Day 14 blood samples for analysis of antibodies against pGSN are to be collected.
- Conditions
- Decompression Sickness
- Being tested
- Sodium Chloride 0.9% Inj pre-exposure, Sodium Chloride 0.9% Inj post-exposure, Recombinant human plasma gelsolin pre-exposure, Recombinant human plasma gelsolin post-exposure, Hyperbaric chamber
- Keywords
- rhu-pGSN, decompression, hyperbaric
- Medical subject headings
- Decompression Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride 0.9% Inj pre-exposureDrug
Also called Normal saline
Sterile normal saline 0.9% administered IV as a placebo immediately before hyperbaric chamber exposure
Sodium Chloride 0.9% Inj post-exposureDrug
Also called Normal saline
Sterile normal saline 0.9% administered IV as a placebo immediately after hyperbaric chamber exposure
Recombinant human plasma gelsolin pre-exposureDrug
Also called rhu-pGSN
rhu-pGSN administered IV at a dose of 24 mg/kg immediately before hyperbaric chamber exposure
Recombinant human plasma gelsolin post-exposureDrug
Also called rhu-pGSN
rhu-pGSN administered IV at a dose of 24 mg/kg immediately after hyperbaric chamber exposure
Hyperbaric chamberOther
High-pressure profile equivalent 35 minutes at a depth of 30 meters of sea water
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Sterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and immediately after exposure Receives: Drug: Sodium Chloride 0.9% Inj pre-exposure; Drug: Sodium Chloride 0.9% Inj post-exposure; Other: Hyperbaric chamber |
| rhu-pGSN pre-exposure | Active comparator | rhu-pGSN 24 mg/kg IV immediately prior to hyperbaric chamber exposure, and sterile normal saline 0.9% IV immediately after exposure Receives: Drug: Sodium Chloride 0.9% Inj post-exposure; Drug: Recombinant human plasma gelsolin pre-exposure; Other: Hyperbaric chamber |
| rhu-pGSN post-exposure | Active comparator | Sterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and rhu-pGSN 24 mg/kg IV immediately after exposure Receives: Drug: Sodium Chloride 0.9% Inj pre-exposure; Drug: Recombinant human plasma gelsolin post-exposure; Other: Hyperbaric chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin (IL)-1β
Change from baseline in blood IL-1β levels at 2 hours after hyperbaric chamber exposure
Measured: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14
Adverse Events
Incidence, causality, and severity of Adverse Events (graded according to the NCI CTCAE version 5.0)
Measured: 14 days
Secondary outcomes (5)
Biomarkers
Change from baseline in biomarker levels, including but not limited to: NOS2, TNFα, IL-6, CCL2, CCL5, and microparticles
Measured: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14
Gas bubbles
Cardiac Echo to screen for vascular gas emboli (VGE) using a phase array ultrasonic probe
Measured: At baseline, and 30, 60, 120, and 240 minutes after exposure
Questionnaire
Doolette well-being questionnaire to screen for clinical decompression sickness (DCS)
Measured: 60 minutes after hyperbaric chamber exposure
pGSN levels
Blood levels of plasma gelsolin
Measured: At baseline, during and after exposure, and afterward at 240 minutes, at 24 hours, and at day 14
anti-pGSN antibodies
Blood levels of anti-plasma gelsolin antibodies
Measured: Baseline, and at day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Aug 2025
- Primary completion30 Sep 2025
- Study completion30 Nov 2025
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 Decompression SicknessStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAegis Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216366
- Sponsor's protocol ID
- BTI-204
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bhat AR, Sethuraman K, Arya AK, Cha YS, Liang Y, Walia D, Imtiyaz Z, Lee Y, Moayedi S, Sward D, Chew A, Badjatia N, Thom SR. Myelin Basic Protein Expressing Microparticles Predict Neurologic Morbidity Risk From Acute Carbon Monoxide Poisoning. Crit Care Med. 2026 Aug 1;54(8):2066-2075. doi: 10.1097/CCM.0000000000007204. Epub 2026 Jun 3.
PubMed 42233740
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety/Tolerability of IV Rhu-pGSN as a Pre- or Post-Exposure Intervention to Mitigate Proinflammatory Responses to Decompression After High Pressure in a Hyperbaric Chamber
- ClinicalTrials.gov ID
- NCT06216366
- Acronym / sponsor ID
- BTI-204
- Conditions
- Decompression Sickness
- Keywords
- rhu-pGSN, decompression, hyperbaric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BioAegis Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 Jan 2024 (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.
Healthy trained SCUBA divers will be randomized into three groups and exposed to a high-pressure profile in a hyperbaric chamber. The high-pressure profile simulates the pressure at a depth of 30 meters of sea water (MSW) for 35 minutes. In the control group, the subjects will receive intravenous normal saline immediately before and after the high-pressure exposure. The second group will receive intravenous recombinant human gelsolin (rhu-pGSN) 24 mg/kg immediately prior to the exposure, and saline post-exposure. The third group will receive saline pre-exposure and rhu-pGSN post-exposure. Blood samples will be collected at multiple time points pre- and post-exposure to assess levels of inflammatory markers, including interleukin (IL)-1β. Other assessments include screening for gas bubbles, a validated questionnaire to assess the incidence of clinical decompression sickness (DCS), measurement of plasma gelsolin (pGSN) levels, and measurement of anti-pGSN antibodies.
Detailed description
This is a prospective, randomized, double-blind, placebo-controlled study in healthy volunteers who have been trained for SCUBA diving.
The study will be performed in the hyperbaric chamber at the University of Maryland. Healthy trained divers will be exposed to a high-pressure profile known to cause decreased plasma gelsolin (pGSN), increased microparticles (MPs), and cytokine changes with no adverse effects such as decompression sickness (DCS). The intervention with recombinant human plasma gelsolin (rhu-pGSN) is patterned after the animal model of DCS where rhu-pGSN administration prior to or after decompression abrogated organ injuries concurrent with inhibiting elevations of MPs and intra-particle interleukin (IL)-1β concentration.
There will be three experimental groups. The control subjects will receive intravenous sterile 0.9% saline immediately before and immediately after the 35-minute 30 meters of sea water (MSW) exposure. A second group will receive intravenous rhu-pGSN 24 mg/kg immediately prior to the high pressure exposure and sterile saline post-exposure. The third group will receive sterile saline prior to the exposure and 24 mg/kg rhu-pGSN post-exposure. Development of DCS is not anticipated based on previous experience with 30 MSW exposure for 35 minutes.
Once informed consent is obtained, the following assessments/procedures will be performed:
- Confirm the potential participant is healthy and has been trained as a SCUBA diver.
- Record medical history, including concomitant medications.
- Perform pregnancy test (urine or blood) for women of childbearing potential.
- Perform vital signs and physical examination.
- Perform EKG.
- Measure CBC and metabolic profile lab tests at local laboratory.
- Collect pretreatment blood samples for measurement of pGSN and analysis of antibodies against pGSN.
- Perform Cardiac Echo for bubbles.
- Collect aliquots of blood for subsequent biomarker assays (including IL-1β, pGSN, nitric oxide synthase [NOS2], tumor necrosis factor [TNF]) and microparticles for analysis.
- If eligibility criteria are satisfied, the subject will be randomized 1:1:1 (rhu-pGSN pre high pressure exposure:rhu-pGSN post high pressure exposure:saline placebo). After reconstitution to 200 mg in a final volume of 5 mL in a 10-mL vial, rhu pGSN is not to be kept at room temperature for >2 hours prior to beginning the IV push. Study drug is administered by an IV push through a 0.2 μm filter. The syringe, filter, and extension tubing for the IV push of study drug are to be connected as close to the subjects as possible. Each subject will receive 2 IV study injections. No subject will receive more than 1 dose of rhu-pGSN.
- Subject will be exposed to high pressure (30 meters salt water [MSW] for 35 minutes) and followed up for 24 hours and again at day 14.
- A well-being questionnaire will be administered.
Before the 30 MSW exposure, blood will be obtained from all subjects for pre-exposure measurements. A second sampling will be obtained after 30 minutes post initiation of the exposure to high pressure while still at pressure in the hyperbaric chamber and before decompression to assess whether inflammatory changes occurring due to pressure and before decompression are altered by rhu-pGSN when administered pre-exposure to high pressure. Blood specimens will be obtained at 60, 120 and 240 minutes after decompression.
Prior to, and following the 30 MSW exposure, all subjects will be screened for gas bubbles (vascular gas emboli [VGE]) using a phase array ultrasonic probe. Intravascular bubbles are thought to play a role in the evolution of DCS. Preliminary work has demonstrated that rhu-pGSN can lyse inflammatory MPs and ~28% of MPs contain a gas phase of nitrogen dioxide that can serve as a nucleation site for bubble formation. Therefore, this work will also evaluate whether rhu-pGSN can prevent bubble production.
The Doolette well-being questionnaire will be administered 60 minutes after decompression.
On Day 14 blood samples for analysis of antibodies against pGSN are to be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Sodium Chloride 0.9% Inj pre-exposure, Drug: Sodium Chloride 0.9% Inj post-exposure, Other: Hyperbaric chamberSterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and immediately after exposure |
| rhu-pGSN pre-exposure | Active comparator | Drug: Sodium Chloride 0.9% Inj post-exposure, Drug: Recombinant human plasma gelsolin pre-exposure, Other: Hyperbaric chamberrhu-pGSN 24 mg/kg IV immediately prior to hyperbaric chamber exposure, and sterile normal saline 0.9% IV immediately after exposure |
| rhu-pGSN post-exposure | Active comparator | Drug: Sodium Chloride 0.9% Inj pre-exposure, Drug: Recombinant human plasma gelsolin post-exposure, Other: Hyperbaric chamberSterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and rhu-pGSN 24 mg/kg IV immediately after exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Experienced healthy trained female or male SCUBA divers without known underlying comorbidities
- Age ≥18
- Informed consent obtained from subject
- During the course of the study starting at screening and for at least 3 months after their final study treatment:
Key exclusion criteria (11 listed)
- Any co-morbidity contraindicating SCUBA diving
- Pregnant or lactating women
- History of unrepaired cardiac shunt or echocardiographic evidence of patent foramen ovale or atrial septal defect
- Any active underlying conditions including but not limited to cancer or other illness treated with systemic chemotherapy, immunomodulatory biologics, or radiation therapy during the last 360 days or expected to be treated in the upcoming 120 days
- Refusal or inability to use adequate contraception
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 |
|---|---|---|
| Sodium Chloride 0.9% Inj pre-exposureAlso: Normal salineSterile normal saline 0.9% administered IV as a placebo immediately before hyperbaric chamber exposure | Drug | Control, rhu-pGSN post-exposure |
| Sodium Chloride 0.9% Inj post-exposureAlso: Normal salineSterile normal saline 0.9% administered IV as a placebo immediately after hyperbaric chamber exposure | Drug | Control, rhu-pGSN pre-exposure |
| Recombinant human plasma gelsolin pre-exposureAlso: rhu-pGSNrhu-pGSN administered IV at a dose of 24 mg/kg immediately before hyperbaric chamber exposure | Drug | rhu-pGSN pre-exposure |
| Recombinant human plasma gelsolin post-exposureAlso: rhu-pGSNrhu-pGSN administered IV at a dose of 24 mg/kg immediately after hyperbaric chamber exposure | Drug | rhu-pGSN post-exposure |
| Hyperbaric chamberHigh-pressure profile equivalent 35 minutes at a depth of 30 meters of sea water | Other | Control, rhu-pGSN post-exposure, rhu-pGSN pre-exposure |
Primary outcome
Interleukin (IL)-1β
Time frame: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14
Change from baseline in blood IL-1β levels at 2 hours after hyperbaric chamber exposure
Adverse Events
Time frame: 14 days
Incidence, causality, and severity of Adverse Events (graded according to the NCI CTCAE version 5.0)
5 secondary outcomes
Biomarkers
Time frame: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14
Gas bubbles
Time frame: At baseline, and 30, 60, 120, and 240 minutes after exposure
Questionnaire
Time frame: 60 minutes after hyperbaric chamber exposure
pGSN levels
Time frame: At baseline, during and after exposure, and afterward at 240 minutes, at 24 hours, and at day 14
anti-pGSN antibodies
Time frame: Baseline, and at day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 42233740Bhat AR, Sethuraman K, Arya AK, Cha YS, Liang Y, Walia D, Imtiyaz Z, Lee Y, Moayedi S, Sward D, Chew A, Badjatia N, Thom SR. Myelin Basic Protein Expressing Microparticles Predict Neurologic Morbidity Risk From Acute Carbon Monoxide Poisoning. Crit Care Med. 2026 Aug 1;54(8):2066-2075. doi: 10.1097/CCM.0000000000007204. Epub 2026 Jun 3.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Chloride 0.9% Inj pre-exposure, Sodium Chloride 0.9% Inj post-exposure and Recombinant human plasma gelsolin pre-exposure in people with Decompression Sickness, run by BioAegis Therapeutics Inc. 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 2 Oct 2026. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin (IL)-1β (time frame: At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14). The study lists 2 primary outcomes in all. 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 NCT06216366, 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 2 Oct 2026.