Avecho Biotechnology has signed up the first participants for a Phase I pharmacokinetic human clinical trial to measure the safety and absorption profile of its CBD soft-gel product.
The study will compare absorption at 75mg and 150mg doses, in alignment with the TGA’s specified maximum daily dose of 150mg for over-the-counter products.
Dosing will begin in Adelaide in October, with 16 participants receiving two separate doses over a two-week period.
The study will support Avecho’s strategic focus of developing pharmaceutical-grade CBD products, leveraging its proprietary TPM formulations.
It has been designed to form a key part of a future regulatory submission, and to inform ongoing research and development for Avecho’s CBD product portfolio and potential commercial partnerships.
CEO Dr Paul Gavin said: “We are delighted to progress enrolment of healthy volunteers for this study and to commence formal clinical assessment of Avecho’s CBD soft-gel product.”
High level results are expected in December 2021.