Not Yet RecruitingPhase 2

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

24 participantsStarted 2026-04

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 range18 Years – 55 Years

SexALL

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.
✓. 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

What they're measuring

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

Defensive behavior: Joystick Operated Runway Task (JORT) Flight Intensity

Timeframe: 4 hours post-dose, Day 2 Treatment period 1 and Day 2 Treatment period 2

Defensive behavior: Joystick Operated Runway Task Risk Assessment Intensity

Timeframe: 4 hours post-dose, Day 2 Treatment Period 1 and Day 2 Treatment period 2

Subjective dread during Joystick Operated Runway Task (JORT)

Timeframe: 4 hours post-dose, Day 2 Treatment Period 1 and Day 2 Treatment period 2

Approach-avoidance learning: reward-punishment sensitivity index

Timeframe: 4 hours post-dose, Day 2 Treatment period 1 and Day 2 Treatment period 2

Approach-avoidance learning: punishment sensitivity index

Timeframe: 4 hours post-dose, Day 2 Treatment period 1 and Day 2 Treatment period 2

Default Mode Network connectivity (fMRI)

Timeframe: 7 hours post dose, Day 2 Treatment period 1 and Day 2 Treatment period 2

Trial details

NCT IDNCT07478744

SponsorSynendos Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Andrea Chicca

+41783008789 andrea.chicca@synendos.com

View on ClinicalTrials.gov More Generalized Anxiety Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

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.
✓. 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.