Ocean Springs

Researchers are conducting a Phase 2, two-part study to evaluate the safety and tolerability of GEn-1124 in adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). This randomized, double-blind, placebo-controlled, dose escalation study aims to understand the pharmacokinetics, pharmacodynamics, safety, and tolerability of the investigational drug GEn-1124 when given early after ARDS diagnosis. Participants will receive GEn-1124 or placebo through a 2-hour intravenous infusion as soon as possible after diagnosis. A second dose will be given about 8 hours after the first, followed by twice daily doses for the next 5 days. The study includes careful dose escalation and monitoring by an independent Safety Review Committee. Throughout the study, participants will be followed for up to 60 days after the first dose or until death. Researchers will monitor serious adverse events and treatment-related side effects to assess safety and tolerability. The study collects data on how the drug behaves in the body and its biological effects, with close observation during dosing and follow-up periods.

The NOVOCLEAR™ Device is a radiofrequency-based hand-held device intended to treat chronic rhinitis by delivering pulsed field energy to soft tissues in the nasal airway, including the posterior nasal nerve distribution. The NOVOCLEAR™ Device is used with the AVENTIX™ PFX System. The AVENTIX™ PFX System is a radiofrequency-based electrosurgical system designed to deliver non-thermal pulsed field energy to the targeted tissue. This is a non-significant risk, prospective, multi-center, single arm study to evaluate the safety, effectiveness and tolerability of the NOVOCLEAR™ Device used with the AVENTIX™ PFX System.