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
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.
• Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants must agree not to donate sperm or ova from the time of the first administration of study drug (T1, D2) until 3 months after the participant's last visit.
• Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the current version of the ICH GCP Guideline E6 and applicable regulations, before completing any study-related procedures.
• Have an understanding, ability, and willingness to fully comply with study procedures as detailed in the Study Protocol and ICF.