Wednesday, December 08, 2021 10:32:06 PM
DehydraTECH-CBD manufacturing for this study is complete and the clinical test articles have been delivered to the study location where dosing is expected to begin in mid-November or thereabouts, and dosing is expected to be complete by mid-December. Thereafter, the BP findings are expected to be reportable by the end of January, 2022.
HYPER-H21-3 will be conducted in 16 adult volunteers and will utilize a single dose of 300mg of DehydraTECH-CBD. This study is designed to evaluate acute pulmonary hypertension and cardiovascular effects under severe stress. Exposure to acute reductions in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary vasoconstriction ("HPV") and, as a consequence of this HPV response, pulmonary arterial pressure increases. If this increase in pressure becomes too high, as is the case in many cardiac pathologies, an excess of fluid in the lungs can occur that causes difficulty with breathing. The extent to which DehydraTECH-CBD may act as a novel treatment for HPV, and potentially as an alternative treatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate the effect of DehydraTECH-CBD on pulmonary vascular function in normotensive individuals exposed to hypoxia. The magnitude of HPV, blood pressure, heart rate, blood samples, and pulmonary gas exchange data will be collected and analyzed.
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