New drug aims to prevent Diver's bends
NCT ID NCT06216366
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an experimental drug called rhu-pGSN can reduce harmful inflammation caused by rapid decompression after high-pressure exposure. Thirty-six healthy, trained divers will be placed in a hyperbaric chamber to simulate a deep dive. Some will receive the drug before or after the exposure, while others get a placebo. Researchers will measure inflammatory markers in the blood and check for symptoms of decompression sickness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human plasma gelsolin (rhu-pGSN)
- What this could lead to
- If it works, this could point toward a treatment to prevent or reduce decompression sickness in divers and others exposed to high pressure.
- What could go wrong
- This is a small, early-phase trial in healthy divers, not patients. The drug may not reduce inflammation or prevent symptoms, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Experienced healthy trained female or male SCUBA divers without known underlying comorbidities 2. Age ≥18 3. Informed consent obtained from subject 4. 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 Exclusion Criteria: 1. Any co-morbidity contraindicating SCUBA diving 2. Pregnant or lactating women 3. History of unrepaired cardiac shunt or echocardiographic evidence of patent foramen ovale or atrial septal defect 4. 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 5. Refusal or inability to use adequate contraception 6. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days 7. Any acute illness or vaccination in the previous 30 days 8. History of alcohol or recreation drug use disorder 9. Known allergy to study drug or excipients 10. Weight \>125 kg 11. Unsuitable for study participation, in the opinion of the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
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