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

Summary

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.

Timeline

Start

2026-04-22

Primary completion

2027-01

Completion

2027-01

Drugs

Indications