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Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers

NCT06216366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-15

No results posted yet for this 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

  • Decompression Sickness

Interventions

DRUG

Sodium Chloride 0.9% Inj pre-exposure

Sterile normal saline 0.9% administered IV as a placebo immediately before hyperbaric chamber exposure

DRUG

Sodium Chloride 0.9% Inj post-exposure

Sterile normal saline 0.9% administered IV as a placebo immediately after hyperbaric chamber exposure

DRUG

Recombinant human plasma gelsolin pre-exposure

rhu-pGSN administered IV at a dose of 24 mg/kg immediately before hyperbaric chamber exposure

DRUG

Recombinant human plasma gelsolin post-exposure

rhu-pGSN administered IV at a dose of 24 mg/kg immediately after hyperbaric chamber exposure

OTHER

Hyperbaric chamber

High-pressure profile equivalent 35 minutes at a depth of 30 meters of sea water

Sponsors & Collaborators

  • BioAegis Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2025-10-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216366 on ClinicalTrials.gov