Status:
ACTIVE_NOT_RECRUITING
Rhu-pGSN to Mitigate Proinflammatory Responses to Decompression in Healthy SCUBA Divers
Lead Sponsor:
BioAegis Therapeutics Inc.
Conditions:
Decompression Sickness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mete...
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled study in healthy volunteers who have been trained for SCUBA diving. The study will be performed in the hyperbaric chamber at the Un...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06216366
Start Date
August 15 2025
End Date
December 30 2025
Last Update
October 15 2025
Active Locations (1)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201