Avicanna Announces Sponsorship of University of Calgary THC Dose Finding Clinical Trial

Executive Summary

• Avicanna announced the initiation of a new Phase I, randomized, double‑blind, placebo‑controlled dose‑finding clinical trial of its oral THC capsule (AVCN319301b) at the University of Calgary.
• The study will enroll 24 healthy adults and evaluate three single oral doses of THC (6 mg, 9 mg, 15 mg) versus placebo, with primary endpoints focused on anxiety psychometrics.
• The trial leverages Avicanna’s proprietary Solid Self‑Emulsifying Drug Delivery System (SEDDs) technology and aims to generate high‑resolution dose‑response data to define the therapeutic window for oral THC.

Key Details

• Trial Design: Single‑site, crossover study; 24 participants; each receives four dosing sessions (6 mg THC, 9 mg THC, 15 mg THC, placebo) with washout periods.
• Primary Endpoints: Validated psychometric assessments of anxiety and subjective response.
• Secondary Endpoints: Mood and intoxication measures, cardiovascular parameters, circulating stress biomarkers, endocannabinoid system markers, pharmacokinetic profiling.
• Investigational Product: Avicanna’s AVCN319301b THC capsules formulated with SEDDs technology to improve oral absorption of lipophilic cannabinoids.
• Lead Investigators: Dr. Leah Mayo (Assistant Professor) and Dr. Matthew Hill (Professor), University of Calgary Cumming School of Medicine.
• Strategic Significance: Second randomized controlled trial evaluating Avicanna’s proprietary capsule; expands clinical collaboration with the University of Calgary and supports pipeline advancement.
• Quote: “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,” – Dr. Karolina Urban, EVP Medical & Scientific Affairs.

Notable Quotes

• “We are pleased to be expanding our clinical collaborations with the University of Calgary and to be working alongside Dr. Hill and Dr. Mayo… 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.” – Dr. Karolina Urban, Executive Vice President of Medical and Scientific Affairs.