Odyssey Health, Inc. (OTC: ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, announced the successful completion of safety measures for their Phase I Multi-Day Ascending Dosing (MAD) clinical trial. Odyssey’s trial involves administering PRV-002, the Company’s novel drug to treat concussion, to healthy human subjects. For MAD Cohort I, the drug was safe and well tolerated.
Cohort I of the MAD trial was conducted at Nucleus Network, a leading clinical research organization. Cohort I findings were evaluated by the Safety Review Committee. Eight healthy human volunteers received one dose of PRV-002 or placebo for five consecutive days followed by evaluations for abnormal responses. No severe adverse events were noted as PRV-002 was well-tolerated. Vital signs, EKG readings and breathing function were all normal. Blood labs showed no alterations associated with multi-day PRV-002 treatment. Pharmacokinetic analysis showed a direct linear relationship between drug dosing concentration and blood plasma levels for each of the five days of dosing. There was no appreciable accumulation of the drug with consecutive day treatments. Blood levels of PRV-002 were significantly lower on average with intranasal administration than what would be expected with other routes of delivery.
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