Incannex Healthcare Limited has received approval from the Bellberry Human Research Ethics Committee to conduct a bioequivalence/bioavailability clinical trial for their proprietary drug, IHL-42X. This drug is specifically designed for the treatment of obstructive sleep apnoea (OSA). The trial will involve 116 participants and will be managed by Novotech at CMAX Clinical Research in South Australia.
The purpose of this clinical trial is to assess the pharmacokinetics and tolerability of IHL-42X. The data collected from this trial will play a crucial role in future marketing submissions for IHL-42X as a treatment for OSA. Additionally, the trial will run parallel to the opening of an Investigational New Drug (IND) application and a pivotal Phase 2/3 clinical trial.
Obstructive sleep apnoea affects approximately 30 million adults in the United States alone, making it a prevalent condition. However, there are currently no registered prescription drugs available for its treatment. Incannex aims to address this gap with their innovative drug, IHL-42X.