ACTIVE_NOT_RECRUITING

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

Conditions

Decompression Sickness rhu-pGSN decompression hyperbaric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-08-15

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06216366

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

University of Maryland School of Medicine

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: BioAegis Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2025-08-15

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

rhu-pGSN
decompression
hyperbaric

Additional Relevant MeSH Terms

Decompression Sickness