Health Canada approved the amendment of a phase I study by Tetra Bio-Pharma Inc. TBP TBPMF JAM conducted in collaboration with Dr. Jutras-Aswad and the University of Montreal Hospital Research Centre. The study will assess the safety profile of low and moderate doses of inhaled CBD and determine the cognitive, behavioral, and biological effects of CBD in adults who occasionally use cannabis. The clinical trial has been authorized by Health Canada, who also approved an amendment to the research protocol to increase the dosage of the study drug up to 100 mg of CBD to be assessed in the study.
Under the collaboration, Tetra will supply the synthetic cannabidiol investigational drug products and placebo and in exchange will gain access to clinical data collected in the study. The data will include safety, pharmacokinetic, and pharmacodynamic in humans exposed to Tetra's inhaled CBD product.
Guy Chamberland, CEO and chief regulatory officer of Tetra, stated: "we are very pleased to pursue our collaboration with Dr. Jutras-Aswad and the CRCHUM. Dr. Jutras-Aswad is a reference in cannabinoid research, addiction, and mental health. His research meets a public heath need to better understand the impact of cannabinoid use in human health. Together with Dr. Jutras-Aswad and the CRCHUM, one of the largest biomedical and healthcare research centres in Canada, we will advance clinical research and cannabis science in Canada."
Dr. Jutras-Aswad commented, ''there is an urgent need to accelerate the research effort to provide accurate information about the effects of cannabinoids and cannabis. This study will be critical to clarify the psychological, cognitive, and biological effects of CBD at doses that are commonly used by consumers. The approval from Health Canada is a major step in achieving these goals.''
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