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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: Active Phase 2 study of Decompression Sickness, sponsored by BioAegis Therapeutics.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in blood IL-1β levels at 2 hours after hyperbaric chamber exposure
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 |
What the registry record for NCT06216366 still lists
NCT06216366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06216366's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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