This is a single dose study to investigate the efficacy, safety, tolerability and the PK, of SYT-510 in participants who meet diagnostic criteria of GAD. This study represents an evaluation of the effects of SYT-510 in participants meeting DSM-5 GAD diagnostic criteria. As a single dose study, it is designed to evaluate the efficacy of SYT-510 on neurobiological and behavioral markers associated with anxiety and will inform the design of future clinical trials in anxiety disorders. By integrating efficacy / PD, safety, tolerability, and PK measures within the same study framework, the study enables the translational value of the program, ensuring a more comprehensive understanding of SYT-510 effects in patients with generalized anxiety disorders. The plan is to evaluate a single dose of SYT-510 as compared with its matching placebo in a two-way crossover design, separated by a washout period of 7 to 14 days.
Males or females aged 18 to 55 years old (inclusive) at the date of signing the ICF.
Participants who are currently unmedicated and meet the criteria for GAD as defined in the DSM-5 by using the MINI.
Participants must be right-handed.
BMI between 18 and 30 kg/m2, inclusive, at Screening and a minimum weight of 50 kg.
Current or past diseases (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematologic, neurologic, endocrine, immunologic, rheumatologic, dermatologic or other conditions) that may interfere with the execution of the conduct of the study, as per the Investigator's judgment.
Participants with current or recurrent disease or treatment that can interfere with the absorption, metabolism, and elimination of SYT-510. Examples include participants with partial gastrostomy or impaired renal functions.
Participants with significant learning difficulties, uncorrected visual and auditory problems and history of dyslexia.
Participants with a current DSM-5 diagnosis of major depressive disorders or severe depressive symptoms determined by MADRS score > 20.
Crossover
SYT-510
DrugSYT-510 will be administered as a single oral dose in the morning with liquid.
Placebo
DrugMatching placebo will be administered as a single oral dose in the morning with liquid.
BOLD fMRI signal in the amygdala in response to fearful stimuli
Defensive behavior: Joystick Operated Runway Task (JORT) Flight Intensity
The JORT uses a force sensing joystick combined with a two-dimensional runway positioned vertically on a computer monitor to measure one-way active avoidance and two-way active avoidance in response to threat of a white noise burst. Each JORT session generates a time series datafile. These time series files are fed into custom programmed scoring software. This software calculates Flight Intensity and RAI for that session
Defensive behavior: Joystick Operated Runway Task Risk Assessment Intensity
The JORT uses a force sensing joystick combined with a two-dimensional runway positioned vertically on a computer monitor to measure one-way active avoidance and two-way active avoidance in response to threat of a white noise burst. Each JORT session generates a time series datafile. These time series files are fed into custom programmed scoring software. This software calculates Risk Assessment Intensity for that session
Subjective dread during Joystick Operated Runway Task (JORT)
Dread rating on a scale of 1 (no threat) to 10 (maximum dread) .
EEG power across frequency bands
Plasma concentrations of endocannabinoids and ECS related biomarkers
Maximum Observed Concentration (Cmax) of SYT 510
Time of maximal plasma concentration (tmax) of SYT-510
Click on the lead sponsor to view all of their trials.
