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

NCT06216366 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BTI-204
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rhu-pGSN; decompression; hyperbaric

Outcome Measures

Primary Outcomes (2)

• Interleukin (IL)-1β

  Change from baseline in blood IL-1β levels at 2 hours after hyperbaric chamber exposure

  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)

  14 days

Secondary Outcomes (5)

• Biomarkers

  At baseline, during and after exposure, and afterward at 60, 120, and 240 minutes, at 24 hours, and at day 14

• Gas bubbles

  At baseline, and 30, 60, 120, and 240 minutes after exposure

• Questionnaire

  60 minutes after hyperbaric chamber exposure

• pGSN levels

  At baseline, during and after exposure, and afterward at 240 minutes, at 24 hours, and at day 14

• anti-pGSN antibodies

  Baseline, and at day 14

Study Arms (3)

Control

PLACEBO COMPARATOR

Sterile normal saline 0.9% IV immediately prior to hyperbaric chamber exposure, and immediately after exposure

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

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

Drug: Sodium Chloride 0.9% Inj pre-exposure; Drug: Recombinant human plasma gelsolin post-exposure; Other: Hyperbaric chamber

Interventions

Sodium Chloride 0.9% Inj pre-exposure DRUG

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

Also known as: Normal saline

Control; rhu-pGSN post-exposure

Sodium Chloride 0.9% Inj post-exposure DRUG

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

Also known as: Normal saline

Control; rhu-pGSN pre-exposure

Recombinant human plasma gelsolin pre-exposure DRUG

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

Also known as: rhu-pGSN

rhu-pGSN pre-exposure

Recombinant human plasma gelsolin post-exposure DRUG

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

Also known as: rhu-pGSN

rhu-pGSN post-exposure

Hyperbaric chamber OTHER

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

Control; rhu-pGSN post-exposure; rhu-pGSN pre-exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BioAegis Therapeutics Inc.: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Decompression Sickness

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Barotrauma; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: August 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)