Results for Phase I human clinical trial of CBD soft-gel product
Avecho Biotechnology Limited (ASX:AVE) is pleased to share the results of our Australian Phase I Pharmacokinetic (PK) study to characterise the absorption profile of CBD in healthy volunteers.
The primary objective of the study was to determine the single dose pharmacokinetics (PK) of cannabidiol absorbed from a single 75 mg and 150 mg oral dose of our proprietary CBD soft-gel product. These doses align with the TGA’s down-scheduling of CBD.
Both doses showed attractive delivery profiles that would be appropriate for investigation in a range of clinical indications. All PK parameters were well characterised, with this data forming an integral component of future regulatory submissions to the TGA or FDA. Both doses were well tolerated and no adverse events of concern related to the study medication.
This is a significant milestone for Avecho and supports our ambition to deliver more effective treatments in the CBD industry. Our goal now is to progress the necessary steps to register our CBD soft-gel product – and we also anticipate strong interest from potential partners, eager to leverage the capabilities of our novel TPM® technology.