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

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 for the On-Demand Treatment of Acute Anxiety in Patients With Social Anxiety Disorder

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.

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:

1. Ability and willingness to provide written informed consent.
2. Male and female subjects aged 18-65 years, inclusive.
3. Current diagnosis of social anxiety disorder.
4. Liebowitz Social Anxiety Scale total score ≥60.
5. Public Speaking Anxiety Scale total score ≥60.
6. Hamilton Depression Rating Scale score ≤18.

Exclusion Criteria:

1. Suicide attempts and/or suicidal ideation in the past 2 years or currently at risk of suicide in the opinion of the investigator.
2. History of bipolar disorder, schizophrenia, psychosis, seizures, delusional disorders, obsessive-compulsive disorder, or autism spectrum disorder.
3. Posttraumatic stress disorder or an eating disorder in the past 6 months.
4. Substance or alcohol use disorder in the past 6 months or positive in drug/alcohol screening.
5. Psychotherapy in the past 6 months.
6. Psychotropic medication in the past 2 months.
7. Current or planned pregnancy or nursing during the trial period.
8. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, or interference with study objectives.