Phase 2a Study to Evaluate the Effects and Safety of a Single Dose of SYT-510 in Adults with Generalized Anxiety Disorder

What this Trial Is About

Researchers are evaluating the effects of a single dose of SYT-510 in adults aged 18 to 55 who meet the DSM-5 criteria for Generalized Anxiety Disorder GAD. This phase 2a study aims to assess the efficacy, safety, tolerability, and pharmacokinetics of SYT-510 compared to a placebo using a two-way crossover design separated by a 7 to 14 day washout period. The trial focuses on neurobiological and behavioral markers related to anxiety to help guide future clinical trials in anxiety disorders. Participants will receive a single oral dose of SYT-510 or matching placebo in the morning with liquid during each treatment period. The two treatment periods are separated by a washout interval. This crossover design allows each participant to receive both SYT-510 and placebo. The study integrates evaluation of pharmacodynamics, safety, and tolerability within the same framework. During the study, participants will undergo various assessments including brain imaging fMRI to measure amygdala response and brain connectivity, behavioral tests such as the Joystick Operated Runway Task, and self-reported anxiety inventories. Blood samples will be collected to analyze plasma concentrations of SYT-510 and related biomarkers. Safety is monitored through adverse event tracking, physical exams, vital signs, ECGs, and laboratory tests. The total study duration includes treatment days and follow-up visits up to 11 weeks after dosing.

A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generalized Anxiety Disorder