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Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
Sponsor: BioAegis Therapeutics Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-08-15
Completion Date
2025-12-30
Last Updated
2025-10-15
Healthy Volunteers
Yes
Conditions
Interventions
Sodium Chloride 0.9% Inj pre-exposure
Sterile normal saline 0.9% administered IV as a placebo immediately before hyperbaric chamber exposure
Sodium Chloride 0.9% Inj post-exposure
Sterile normal saline 0.9% administered IV as a placebo immediately after hyperbaric chamber exposure
Recombinant human plasma gelsolin pre-exposure
rhu-pGSN administered IV at a dose of 24 mg/kg immediately before hyperbaric chamber exposure
Recombinant human plasma gelsolin post-exposure
rhu-pGSN administered IV at a dose of 24 mg/kg immediately after hyperbaric chamber exposure
Hyperbaric chamber
High-pressure profile equivalent 35 minutes at a depth of 30 meters of sea water
Locations (1)
University of Maryland School of Medicine
Baltimore, Maryland, United States