Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

151

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2022

Shorter than P25 for phase_2

Geographic Reach

1 country

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

January 3, 2022

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed

19 days until next milestone

Study Start

First participant enrolled

February 2, 2022

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

March 18, 2025

Completed

Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

January 3, 2022

Results QC Date

February 16, 2025

Last Update Submit

March 12, 2025

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.
Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

Secondary Outcomes (5)

Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score
Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score
Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score
Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score
Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

Study Arms (3)

225 mg BNC210

EXPERIMENTAL

Drug: 225 mg BNC210

675 mg BNC210

EXPERIMENTAL

Drug: 675 mg BNC210

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

225 mg BNC210DRUG

225 mg BNC210

675 mg BNC210DRUG

675 mg BNC210

PlaceboDRUG

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.