It is the first of three clinical trials aimed at assessing this potential treatment, and dosing of human volunteers has begun
Lexaria Bioscience Corp () () revealed that its first human clinical trial assessing its DehydraTECH CBD technology to treat high blood pressure - HYPER-H21-1 - is now officially underway.
It is the first of three clinical trials aimed at assessing this potential treatment, and dosing of human volunteers has begun, the company told investors.
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"Dosing is expected to be completed, on schedule, within several weeks, and we may be in a position to report preliminary data in July or thereabouts," said Chris Bunka, Lexaria CEO.
"Despite challenges in launching a human clinical study during a global pandemic, Lexaria’s Europe-based research partners have done an excellent job of balancing the need for scientific validation for a potential new hypertension treatment, with the required safety protocols currently in place."
This first trial is a randomized, double-blinded, controlled human clinical study expected to involve 24 volunteers with symptoms of either pre-hypertension or mild hypertension.
A single 300mg dose of an advanced DehydraTECH TM 2.0 CBD formulation will be evaluated relative to a concentration-matched control without Lexaria’s DehydraTECH enhancements.
The main objectives will assess time series blood pressure and heart rates, while secondary objectives include speed and rate of absorption of the CBD and its main metabolites.
Since a large array of data points will be generated, final reporting on this study is likely to be in early September, this year, noted Lexaria.
In all, there are five studies in Lexaria’s 2021 hypertension program - three human and two animal - which expected to generate data required to further support the validity of using DehydraTECH-processed CBD as a potential hypertension treatment across various applications.
Lexaria has received 18 granted patents internationally, including issuances in the European Union and Australia, specifically to use DehydraTECH-processed CBD to treat heart disease.
Contact the author at giles@proactiveinvestors.com
