An Ascending, Single and Multiple Dose(s), Double-Blind, Randomized, Placebo Controlled Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous OV350 in Healthy Male and Female Participants

The study will be a Phase 1, single-center, randomized, double-blind, placebo-controlled, inpatient study of the safety and tolerability of single and multiple ascending dose(s) of intravenous OV350 in healthy male and female participants. The study is comprised of two parts: Part A, approximately 5 single ascending dose (SAD) administered as a 10-minute infusion starting at 50mg; and Part B, approximately 4 multiple ascending doses (MAD) administered once a day for 7 days. SAD and MAD cohorts can be conducted in parallel but dosing in a MAD cohort will only be initiated after the dose is cleared in a SAD cohort. The study sponsor, the study principal investigator (PI), medical monitor, and a pharmacokineticist will review data summaries from each cohort and recommend whether to proceed with dose escalation or MAD cohort dosing. The study will assess the safety profile of intravenous OV350 on ECG parameters, VS, physical and neurological examinations, hematology and chemistry laboratory results and adverse events (AEs). In addition, neurophysiologic PD variables in the study are quantitative EEG, particularly the timing and extent of EEG changes in relation to the doses administered. In each cohort, a sentinel group of 2 participants (1 active: 1 placebo) will be randomized and dosed ahead of the rest of the cohort. These 2 participants will be monitored for 2 days until the end of the in-patient portion of Part A (Day 3) and for 8 days for the in-patient portion of Part B (Day 9) before their available data will be reviewed by the Principal Investigator. The remaining 6 participants will be dosed once the Principal Investigator has concluded that it is safe to proceed with the rest of the cohort. Participants involved in SAD cohorts will not be eligible for inclusion in MAD cohorts, ensuring unique enrollment across both segments. Monitoring visits by the CRO to the study site will be made periodically during the study to ensure that all aspects of the protocol are followed.