Avicanna says it is sponsoring a new clinical trial at the University of Calgary that will examine how different oral doses of THC affect anxiety, stress and related responses in healthy adults.

According to the company, the Phase I study is randomized, double-blinded, placebo-controlled and will be conducted at a single site through the University of Calgary’s Cumming School of Medicine. The trial is being led by Dr. Leah Mayo, an assistant professor, with support from Dr. Matthew Hill, a professor at the university.

The study will enroll 24 healthy adult participants. Each participant will receive single oral doses of THC during separate visits, including 6 milligrams, 9 milligrams and 15 milligrams, as well as a placebo. The dosing sessions will be separated by washout periods.

Avicanna says the main goal is to measure anxiety and subjective response using validated psychometric assessments. Researchers will also track mood, intoxication, cardiovascular activity, stress-related biomarkers, markers tied to the endocannabinoid system and pharmacokinetic data. The company says the aim is to generate more detailed dose-response data and better define the therapeutic window for oral THC, while also examining how responses can vary from person to person.

The trial is using Avicanna’s proprietary THC capsules, known as AVCN319301b, which are made with the company’s Solid Self-Emulsifying Drug Delivery System technology. Avicanna says the delivery method is designed to improve absorption and reduce some of the variability commonly associated with oral cannabinoid products due to poor water solubility.

Dr. Karolina Urban, executive vice president of medical and scientific affairs at Avicanna, said, “We are pleased to be expanding our clinical collaborations with the University of Calgary and to be working alongside Dr. Hill and Dr. Mayo, who are internationally recognized for their contribution to cannabinoid science and anxiety research. This Trial represents our second randomized controlled trial that is evaluating our proprietary capsule and marks another important step in advancing our pharmaceutical development pipeline through rigorous, investigator-led research.”

The company says the same capsule is also being used in a previously announced pilot Phase II randomized controlled trial for osteoarthritis in partnership with University Health Network.