A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generaliz… (NCT07478744) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generalized Anxiety Disorder
United Kingdom24 participantsStarted 2026-04-22
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses brain imaging like fMRI and behavioral tasks like the Joystick Operated Runway Task to measure how SYT-510 affects fear and anxiety responses — what does that mean for how many visits I'd need, and how demanding are those tests on someone already dealing with daily anxiety symptoms?
2Since this is a Phase 2a study, it's still in an early stage of testing for effectiveness and safety in humans — what does that mean for how much we currently know about whether SYT-510 is safe and whether it actually helps people with generalized anxiety disorder?
3The trial is measuring things like amygdala activity and defensive behaviors rather than just asking how I feel — does that tell us anything useful about whether the drug might eventually work as a real treatment, or is this more about understanding the science behind it?
4Would it make sense for me to try an established treatment for generalized anxiety disorder first, like an SSRI or therapy, before considering an experimental drug that's still in Phase 2a testing?
5The trial is currently recruiting — what do you think about my specific situation and symptoms, and am I even someone who should be seriously considering this kind of study right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BOLD fMRI signal in the amygdala in response to fearful stimuli
Timeframe: 7 hours post-dose on Day 2 Treatment period 1 and Day 2 Treatment period 2
. 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.
Exclusion criteria
. Current or past diseases (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematologic, neurologic, endocrine, immunologic, rheumatologic, dermatologic or other conditions) that may interfere with the execution of the conduct of the study, as per the Investigator's judgment.
. Participants with current or recurrent disease or treatment that can interfere with the absorption, metabolism, and elimination of SYT-510. Examples include participants with partial gastrostomy or impaired renal functions.
. Participants with significant learning difficulties, uncorrected visual and auditory problems and history of dyslexia.
. Participants with a current DSM-5 diagnosis of major depressive disorders or severe depressive symptoms determined by MADRS score \> 20.
. Substance use disorder within the past 6 months before Screening.
. Any primary diagnosis other than GAD e.g., bipolar disorder, obsessive compulsive disorder, PTSD, psychotic disorder, cognitive impairment, or pervasive development disorder.
. Any psychotic features, including dementia or delirium.
. Experienced suicidal ideation with some intent to act within the 6 months preceding screening or any history of suicidal behavior.
Default Mode Network connectivity (fMRI)
Timeframe: 7 hours post dose, Day 2 Treatment period 1 and Day 2 Treatment period 2
8
Reaction time to fearful faces (fMRI task)
Timeframe: 7 hours post-dose, Day 2 Treatment period 1 and Day 2 Treatment period 2
9
Self reported State Trait Anxiety Inventory (STAI) subscale score
Timeframe: 1 day post-dose, on Day 3 Treatment period 1 and Day 3 treatment period 2