PRV-002 / Odyssey Group International - LARVOL DELTA

A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Odyssey Group International, Inc. | Recruiting ➔ Completed | N=24 ➔ 40 | Trial completion date: Nov 2021 ➔ Sep 2024

Enrollment change • Trial completion • Trial completion date • CNS Disorders • Vascular Neurology

Odyssey Health, Inc. Announces Successful Completion of Phase I Clinical Trial for Concussion Drug (GlobeNewswire) - P1 | N=24 | NCT05033444 | Sponsor: Odyssey Group International, Inc. | "Odyssey Health...announces the completion of all cohorts for its Phase I Single Ascending Dosing (SAD) and Multiple Ascending Dosing (MAD) clinical trial. Odyssey’s trial involved administering PRV-002, the Company’s novel drug to treat concussion, to healthy human subjects. Throughout the trial, the drug was safe and well tolerated....For the SAD component twenty-four (24) subjects were separated into three (3) different groups and received drug at a ratio of 3:1 with placebo. The treatment groups were given either a low, medium, or high-single dose of PRV-002. For the MAD portion there were sixteen (16) subjects separated into two groups of eight and each subject received a single low or high dose for five (5) consecutive days....'We look forward to following the development process of Odyssey’s drug, PRV-002, during Clinical Phase II/III as they determine the efficacy.'"

Trial completion • CNS Disorders

"$ODYY BioMedNewsBreaks – Odyssey Health Inc. (ODYY) Eyes Intranasal Brain Targeting as Key to Success of PRV-002 https://t.co/B66p4HeCK3" (@otcdynamics)