Melbourne-based Nexalis Therapeutics (ASX:NX1) has enrolled the first participant in its Phase 1 clinical trial for IRX-616a, a novel drug-device inhalation aerosol designed to treat Panic Disorder.
The first-in-human study, conducted at the CMAX clinical research unit in Adelaide, marks a significant milestone in developing rapid-onset therapies for acute anxiety conditions.
The trial is a randomised, double-blind, placebo-controlled study involving up to 24 healthy adult volunteers.
Participants will be divided into three sequential dose cohorts to evaluate the pharmacokinetics, safety, and tolerability of the treatment.
To ensure participant safety, the study utilises a sentinel dosing strategy and staggered enrolment, with all dose escalations overseen by an independent Safety Review Committee.
IRX-616a delivers 2.5 mg of cannabidiol per actuation via a pressurised metered-dose inhaler.
By opting for an inhalation route, the therapy aims for rapid systemic absorption while bypassing first-pass hepatic metabolism.
The delivery method is specifically engineered to provide the fast onset of action required to manage acute panic symptoms effectively.
Nexalis CEO Darryl Davies emphasised the importance of the trial, noting that there are currently no FDA-approved inhaled treatments for panic disorder.
The primary objective is to characterise the plasma PK profiles of CBD and its metabolites under fasted conditions.
At the time of reporting, Nexalis Therapeutics' share price was $0.021.