Medicinal cannabis pharmaceutical company AusCann (ASX: AC8) has announced the completion of recruitment and commencement of its first clinical evaluation at an independent clinical site – Nucleus Network.
AusCann said it is conducting a randomised, open-label, cross-over phase 1 study to evaluate the pharmacokinetics of a single dose of two formulations of orally administered THC/CBD combination in healthy volunteers.
It said the primary endpoints of the study are the assessment of the pharmacokinetics of THC, CBD and the main active metabolite of THC (11-hydroxy-THC), after oral doses of 2.5mg:2.5mg and 10mg:10mg of THC:CBD.
The company said the target number plus reserves, of healthy male and female volunteers have been recruited.
One study arm of 14 participants will receive a 2.5mg:2.5mg THC:CBD capsule with cross-over to oil comparator, while the second study arm of 14 participants will receive a 10mg:10mg THC:CBD capsule with a crossover to comparator, with a 14-day washout period between treatments. Dosing of first subjects is complete.
"The study will provide key exposure information to inform dose selection and provide medical professionals with relevant information to assist in prescribing the unique hardshell capsule," said the company in a statement.
According to AusCann CEO Ido Kanyon, “We are very excited to be progressing this important study to provide evidence-based information to medical professionals about our unique hard shell capsule. This is the first of many studies planned by AusCann to better understand and prove the benefits of using controlled dose medicinal cannabis for medical treatment.”
The company said the study is expected to be completed during 2020. The company added it and Nucleus Network will continue to monitor developments in relation to the COVID-19 pandemic and will adjust, if necessary, the study timelines accordingly.