Sponsor: Tonix Pharmaceuticals, Inc. | Status: Not yet recruiting
Start Date: 12/01/2023 | End Date: 12/31/2024
Principal Investigator(s)
Gentry Wilkerson
Secondary Investigator(s)
Description:
Study Design:
This is a single-blind, randomized study to compare safety and changes in cardiovascular and other signs and symptoms, inclusive of behavioral symptoms, of acute cocaine intoxication after a single IV 200 mg injection of TNX-1300 or a single IV injection of placebo in male subjects presenting to the ED. A total of 60 subjects across 4 EDs throughout the United States will participate in this study.
Patient eligibility is determined through a screening process. Blood and urine samples will be collected, a breathalyzer will be performed, cardiovascular and other symptoms of cocaine intoxication will be assessed, and a 12-lead ECG will be performed to verify the presence of drugs of abuse or alcohol and confirm the use of cocaine. Patients must be able to consent for themselves to be eligible for this study. Specific eligibility criteria can be found on the study protocol.
During the Treatment Period, subjects assigned to receive TNX-1300 will receive a single IV injection and subjects randomized to receive placebo will receive the same volume of placebo in a single IV injection of saline. Both injections will be administered over 2 minutes or less.
For both study arms, signs of cocaine intoxication will be assessed at pre-determined time points after treatment (15, 30, 60, 90, 120, 180, 240, and 360 minutes). Blood samples will also be drawn at specific timepoints for assessment of cocaine, cocaethylene, EME, and TNX-1300 levels. Follow-up will occur for all subjects in the ED through 6 hours post-dose and an assessment at 12 hours post-dose will be conducted in the ED or by telephone to assess subject safety/persistence of effects.
The maximum study duration for each subject is approximately 15 hours.
Keywords: cocaine, Tonix