Avicanna backs Calgary THC dose-finding clinical trial

Executive Summary

• Avicanna Inc. has initiated a Phase I, randomized, double-blind, placebo-controlled, dose-finding clinical trial at the University of Calgary's Cumming School of Medicine to evaluate the therapeutic window and interindividual variability of oral THC.
• The study will enroll 24 healthy adult participants who will receive single oral doses of THC (6 mg, 9 mg, and 15 mg) and placebo across separate visits, with primary endpoints focused on validated psychometric assessments of anxiety and subjective response.
• The trial utilizes Avicanna's proprietary AVCN319301b THC capsules, which leverage a solid self-emulsifying drug delivery system (SEDDS) to improve cannabinoid absorption, onset consistency, and non-invasive administration.

Key Details

• Trial Design & Leadership: Single-site, randomized, double-blind, placebo-controlled crossover trial led by Dr. Leah Mayo (Assistant Professor) and Dr. Matthew Hill (Professor) at the University of Calgary.
• Participant Profile: 24 healthy adult participants.
• Dosing Protocol: Single oral doses of THC at 6 mg, 9 mg, and 15 mg, plus placebo, administered across separate study visits with washout periods between dosing sessions.
• Primary Endpoints: Validated psychometric assessments of anxiety and subjective response.
• Secondary Endpoints: Measures of mood and intoxication, cardiovascular parameters, circulating stress biomarkers, endocannabinoid system markers, and pharmacokinetic profiling.
• Investigational Product: Proprietary AVCN319301b THC capsules utilizing solid self-emulsifying drug delivery system (SEDDS) technology.
• Technology Rationale: Addresses the highly lipophilic nature and poor water-solubility of typical cannabinoids, which traditionally suffer from poor absorption and variable onset times; SEDDs enables effective non-invasive, non-inhalation administration.
• Pipeline Context: The same proprietary capsules are concurrently enrolled in a previously announced pilot Phase II randomized controlled trial (RCT) for osteoarthritis with the University Health Network.

Notable Quotes

• Dr. Karolina Urban, Executive Vice-President of Medical and Scientific Affairs: "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."