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NOT YET RECRUITING
NCT07478744
PHASE2

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

Sponsor: Synendos Therapeutics AG

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-04

Completion Date

2027-01

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

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.