Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Social Anxiety Disorder

The study will enroll approximately 500 patients with current diagnosis of social anxiety disorder (SAD). Eligible participants will be randomly assigned to receive either a single oral dose of VQW-765 or placebo in a 1:1 ratio, followed by a psychosocial stress test. 1-2 weeks after the treatment visit, a safety follow-up assessment will be conducted remotely.

Inclusion criteria

• 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.
• Public Speaking Anxiety Scale total score ≥60.
• Hamilton Depression Rating Scale score ≤18.

Exclusion criteria

• 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.
• Psychotherapy in the past 6 months.
• Psychotropic medication in the past 2 months.
• Current or planned pregnancy or nursing during the trial period.
• Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.