TQT Study : Clinic and Bioanalysis completed within 2 months

Drug

Continuous IV Infusion for 24 hr

Study Requirements

NDA submitted; FDA requested additional TQT study

Corporate business target to submit asap

Partnered with Clario for holter set up and ECG analysis

Study Design

36 subjects

3 period Crossover: Test, Placebo, Control

Study outcome

Study Completed and submitted to FDA in 114 days

Contract Award:   October 18^th, 2023

Subjects dosed:   November 11^th  & 18^th, 2023

Bioanalysis:   December  10^th, 2023

FDA submission: February 9^th 2023