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NCT06216366 · ClinicalTrials.gov registry record · Phase 2
Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
A Phase 2 study of Decompression Sickness, sponsored by BioAegis Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06216366 is a Phase 2 study of Decompression Sickness that is active but no longer recruiting, run by BioAegis Therapeutics. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06216366, a Phase 2 study of Decompression Sickness, is active but no longer recruiting, sponsored by BioAegis Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- DRUG Sodium Chloride 0.9% Inj pre-exposure
- DRUG Sodium Chloride 0.9% Inj post-exposure
- DRUG Recombinant human plasma gelsolin pre-exposure
- DRUG Recombinant human plasma gelsolin post-exposure
- OTHER Hyperbaric chamber
Study Locations (1)
Maryland
- University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-08-15 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06216366
The ClinicalTrials.gov registry entry for NCT06216366 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioAegis Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Decompression Sickness appearing as the primary indexed condition, and to 5 interventions - of which Sodium Chloride 0.9% Inj pre-exposure is the first listed.
NCT06216366 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06216366 about?
NCT06216366 is a clinical study titled "Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers". 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 no...
What is the current status of trial NCT06216366?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-08-15. Estimated completion is 2025-12-30.
What conditions does trial NCT06216366 study?
This clinical trial studies the following conditions: Decompression Sickness.
What interventions are being tested in trial NCT06216366?
The interventions under investigation include: Sodium Chloride 0.9% Inj pre-exposure (DRUG), Sodium Chloride 0.9% Inj post-exposure (DRUG), Recombinant human plasma gelsolin pre-exposure (DRUG), Recombinant human plasma gelsolin post-exposure (DRUG), Hyperbaric chamber (OTHER).
Who is sponsoring clinical trial NCT06216366?
This trial is sponsored by BioAegis Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06216366 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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