[PRESS RELEASE] – TORONTO, March 16, 2026 – Avicanna Inc., a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products, announced the initiation of a new Phase I randomized, double-blinded, placebo-controlled, dose-finding clinical trial led by researchers at the University of Calgary’s Cumming School of Medicine.
Study Overview
The trial is led by Dr. Leah Mayo, assistant professor, and supported by Dr. Matthew Hill, professor, at the University of Calgary. This single-site, randomized, double-blind, placebo-controlled crossover trial will enroll 24 healthy adult participants. Participants will receive single oral doses of THC across separate study visits at 6 milligrams, 9 milligrams and 15 milligrams, as well as placebo, with washout periods between dosing sessions.
Primary endpoints focus on validated psychometric assessments of anxiety and subjective response. Secondary endpoints include measures of mood and intoxication, cardiovascular parameters, circulating stress biomarkers, endocannabinoid system markers and pharmacokinetic profiling.
The trial is designed to generate high-resolution dose-response data to better define the therapeutic window of oral THC and to characterize interindividual variability in response.
Investigational Product
The trial utilizes Avicanna’s proprietary AVCN319301b THC capsules, which utilize the company’s Solid Self-Emulsifying Drug Delivery System (SEDDs) technology.
Due to the highly lipophilic nature and poor water-solubility of cannabinoids, typical cannabis formulations have poor absorption and variability of onset. Avicanna’s oral delivery systems offer an effective route for non-invasive and non-inhalation administration of cannabinoids1-4.
The proprietary capsules are also enrolled in a previously announced pilot phase II randomized controlled trial (RCT) for osteoarthritis with the University Health Network. Avicanna’s SEDDs technology has demonstrated robustness and versatility through different drug delivery formats, including several commercial products such as liquid infuser drops, capsules and an extensive pipeline of products currently in the commercialization stage.
“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,” said Dr. Karolina Urban, executive vice president of Medical and Scientific Affairs at Avicanna. “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.”
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1 Maji, et al., Solid self-emulsifying drug delivery system: Superior mode for oral delivery of hydrophobic cargos. Journal of Controlled Release, 337, 2021;646-660.
2 Salawi A. Self-emulsifying drug delivery systems: a novel approach to deliver drugs. Drug Deliv. 2022 Dec;29(1):1811-1823.
3 Khaled, A.; Ayat, A. A.; Mahmoud, E.-B., Self-Emulsifying Drug Delivery Systems: Easy to Prepare Multifunctional Vectors for Efficient Oral Delivery. In Current and Future Aspects of Nanomedicine, Islam Ahmed Hamed, K., Ed. IntechOpen: Rijeka, 2019; p Ch. 4
4 Pathak, Ashish Kumar et al. “Recent advances in self-emulsifying drug delivery system – A review.” Drug Invention Today (2010): 123-129.
