This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single oral dose of VQW-765 compared to placebo in adults with social anxiety disorder.
Ability and willingness to provide written informed consent.
Male and female subjects aged 18-65 years, inclusive.
Current diagnosis of social anxiety disorder.
Liebowitz Social Anxiety Scale total score ≥60.
Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
Posttraumatic stress disorder or an eating disorder in the past 6 months.
Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
Parallel
VQW-765
Drugoral capsule
Placebo
Drugoral capsule
Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) during performance phase, scored from 0-100 with a higher score indicating higher distress.
Subjective Units of Distress Scale (SUDS)
Subjective Units of Distress Scale (SUDS) during anticipation phase, scored from 0-100 with a higher score indicating higher distress.
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S)
State-Trait Anxiety Inventory - State Anxiety Scale (STAI-S), scored from 20 to 80 with higher scores indicating higher anxiety level.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Assessment of safety and tolerability of VQW-765, as measured by spontaneous reporting of adverse events (AEs)
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