Natural medicines developer Bod Australia has concluded the design for a Phase I clinical trial of its pharmaceutical grade cannabis extract in combination with a new delivery system.
The move follows a letter of intent (LOI) signed by the firm to develop various therapeutic products and skincare offerings using the cannabidiol (CBD) extracts produced by Linnea Natural Pharma Solutions (Linnea).
Linnea’s standardised phytocomplex pharmacy grade extracts are said to contain a low volume (0.1%) of tetrahydrocannabinol (THC) with high concentrations of CBD.
The Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of sublingual formulation of the cannabis in 48 healthy subjects.
Bod Australia CEO Jo Patterson said: “The Phase I clinical trial is a crucial step towards establishing a high-growth medicinal cannabis business and builds on the progress made through our LOI with Linnea, medicinal cannabis advisory board and appointment of Mickey Perret to the board.
“Bod Australia is at the forefront when it comes to the development and distribution of evidence-based natural health and skincare products, and the soon-to-commence Phase I clinical trial of our pharmaceutical grade cannabis extract reinforces this.”
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Expected to be completed in nine months, the Phase I trial will be followed by a Phase II trial that will investigate the effectiveness of the extract and delivery system combination for the treatment of patients with epilepsy, chemotherapy-induced nausea and vomiting, and multiple sclerosis.
The firm is currently seeking to perform the Phase I trial at various hospitals in the country’s Victoria state.