A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of an acute dose of BNC210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).

Detailed Description
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This is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 14 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study intervention (225 mg BNC210, 675 mg BNC210 or placebo) and approximately 1 hour later participate in a speaking challenge. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Official Title
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A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of BNC210 Compared to Placebo for the Acute Treatment of Social Anxiety Disorder

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Drug: 225 mg BNC210
* Drug: 675 mg BNC210
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has a current diagnosis of Social Anxiety Disorder (SAD) as defined in DSM-5 and confirmed by Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID-5-CT). Liebowitz Social Anxiety Scale (LSAS) total score of ≥70 Suitable contraception use in line with protocol requirements Ability to swallow tablets Exclusion Criteria: History of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other Axis I disorder, other than SAD Hamilton Rating Scale for Depression (HAM-D) score of ≥18 Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening. Previous participation in a study that involved a speaking challenge. Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 225 mg BNC210<br> | Drug: 225 mg BNC210<br>* 225 mg BNC210<br>|
| Experimental: 675 mg BNC210<br> | Drug: 675 mg BNC210<br>* 675 mg BNC210<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Units of Distress Scale (SUDS) - speaking challenge performance phase |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Units of Distress Scale (SUDS) - speaking challenge anticipation phase |  | 1 Day | 
| State-Trait Anxiety Inventory (State component; STAI-State) |  | 1 Day | 
| Self-Statements During Public Speaking Scale (Negative Self-Statements subscale; SSPS-N) |  | 1 Day |