Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT06216366
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06216366
Study Brief:
Protocol Section:
NCT06216366