NCT07478744

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

A Study Investigating the Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Dose of SYT-510 in Participants Who Meet DSM-5 Diagnostic Criteria for Generalized Anxiety Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Synendos Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	SYT-510	SYT-510 will be administered as a single oral dose in the morning with liquid.
DRUG	Placebo	Matching placebo will be administered as a single oral dose in the morning with liquid.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-03-17
• Last updated: 2026-03-17