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Cardiol Therapeutics Initiates Health Canada Approved Phase 1 Clinical Study of CardiolRx(TM)
Oakville, Ontario--(Newsfile Corp. - August 26, 2020) - Cardiol Therapeutics Inc. ( TSX: CR...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Initiates Health Canada Approved Phase 1 Clinical Study of CardiolRx(TM)Study Designed to Support Cardiol Therapeutics' Phase 2 International Trial in Acute MyocarditisOakville, Ontario--(Newsfile Corp. - August 26, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) (\"Cardiol\" or the \"Company\"), a leader in the development of pharmaceutical cannabidiol formulations for the treatment of cardiovascular diseases, including heart failure and acute myocarditis, is pleased to announce the initiation of its Health Canada approved Phase 1 clinical study of CardiolRx™. CardiolRx is an extra strength formulation of pharmaceutical cannabidiol that has been formulated to set the highest industry standard for purity, consistency, and stability. Cardiol's Phase 1 clinical trial is a double-blind, placebo-controlled, randomized study to assess safety, tolerability, and pharmacokinetics of single followed by multiple day ascending doses of CardiolRx administered orally in up to 55 healthy adult subjects, both in the fasting and fed states. The study is expected to be completed during Q4, 2020, and is believed to represent the first Health Canada approved study of a high concentration (100 mg/mL) cannabidiol formulation that contains virtually no THC (<5 ppm). This level of purity is extremely important for patient populations who should not take THC, particularly children, where THC can impact brain development, and older individuals who wish to avoid intoxication and who may be more susceptible to adverse drug effects. By measuring standard safety parameters and the pharmacokinetics of CardiolRx, including the degree of drug absorption and resulting blood levels at escalating doses, the Phase 1 study will provide important information to optimize dosing levels for the Company's planned Phase 2 international trial in acute myocarditis. Cardiol's acute myocarditis trial has been designed by an independent steering committee comprising highly distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, and Charité Hospital Berlin.Acute...