Incannex receives ethics approval for bioequivalence/bioavailability clinical trial for ihl-42x, the company's proprietary drug for treatment of obstructive sleep apnoea (‘osa')

Highlights: incannex has received approval from bellberry human research ethics committee (‘hrec') to commence the bioavailability/bioequivalence (‘ba/be') clinical trial to assess the pharmacokinetics and tolerability of ihl-42x the trial will include 116 participants at cmax clinical research in south australia and will be managed by novotech data from the clinical trial will be a critical component of future marketing submissions for ihl-42x for treatment of osa the trial will be conducted in parallel to the ind opening and pivotal phase 2/3 clinical trial osa is highly prevalent, affecting approximately 30 million adults in the united states alone and there are no registered prescription drugs available to patients for the treatment of osa the design of the ba/be trial is consistent with fda recommendations as part of the required research required to undertake a new drug application. melbourne, australia, july 06, 2023 (globe newswire) -- incannex healthcare limited (nasdaq: ixhl) (asx: ihl), (‘incannex' or the ‘company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that incannex has received approval from bellberry human research ethics committee to commence a bioavailability/bioequivalence (‘ba/be') clinical trial on ihl-42x, the company's proprietary drug product for treatment of obstructive sleep apnoea.
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