The grandview at las vegas trial#

Pharmacokinetic analysis showed a direct linear relationship between drug dosing concentration and blood plasma levels across all three cohorts of SAD. Blood labs showed no alterations associated with the PRV-002 treatment. Vital signs, EKG readings, sleep patterns and breathing function were all normal. No severe adverse events were noted, as PRV-002 was well-tolerated.

Eight healthy human volunteers received one dose of PRV-002 or placebo followed by evaluations for abnormal responses. Cohort III was unblinded and evaluated by the Safety Review Committee (SRC). The final cohort, Cohort III, received the highest drug dose in the SAD trial.

The grandview at las vegas trial#

The SAD trial was conducted by Nucleus Network, a leading clinical research organization. If this turns out to be the case, not only can the targeted effects of the drug be more efficacious the drug will likely have less potential side effects,вЂќ commented Dallas Hack, MD, member of the Safety Review Committee. I am especially excited to see the overall low levels of PRV-002 in the blood supporting the hypothesis that more drug is getting to the brain itself when administered with the intranasal device. We have unanimously approved the start of MAD Cohort I. вЂњAfter reviewing the data from Cohort III and completing the SAD analysis, I have strong confidence that PRV-002 will continue to show safety during the Multiple Ascending Dosing (MAD) portion of the Phase I clinical trial where subjects are treated once daily for five straight days. A single concussion can significantly increase the risk of AlzheimerвЂ™s Disease and other neuropsychiatric disorders. Concussions represent an вЂunmetвЂ™ medical need and affect millions worldwide.

For SAD, the drug was safe and well tolerated. OdysseyвЂ™s trial involves administering PRV-002, the CompanyвЂ™s novel drug to treat concussion, to healthy human subjects. (OTC Pink: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, today announced the completion of all three cohorts in their Phase I Single Ascending Dosing (SAD) clinical trial. Las Vegas, NV, J(GLOBE NEWSWIRE) - Odyssey Health, Inc.