Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

NCT ID: NCT06510504

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2025-09-19

Brief Summary

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The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

Detailed Description

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This is a randomized, double-blind, placebo-controlled, 2-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study medication (225 mg BNC210 or placebo) and approximately 1 hour later participate in a behavioral assessment task. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Conditions

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Social Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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225 mg BNC210

Group Type EXPERIMENTAL

225 mg BNC210

Intervention Type DRUG

225 mg BNC210

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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225 mg BNC210

225 mg BNC210

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A current diagnosis of social anxiety disorder as defined in the DSM-5.
* A Liebowitz Social Anxiety Scale total score of ≥60.
* Suitable contraception use in line with protocol requirements.
* Ability to swallow tablets.

Exclusion Criteria

* History of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorders, anorexia or bulimia, body dysmorphic disorder, PTSD, autism-spectrum disorder or obsessive-compulsive disorder, or any other Axis I or II disorder which is currently the primary focus of treatment over social anxiety disorder.
* Hamilton Rating Scale for Depression 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bionomics Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AFFIRM-1 Study Site

Encino, California, United States

Site Status

AFFIRM-1 Study Site

La Jolla, California, United States

Site Status

AFFIRM-1 Study Site

Los Angeles, California, United States

Site Status

AFFIRM-1 Study Site

Oceanside, California, United States

Site Status

AFFIRM-1 Study Site

San Diego, California, United States

Site Status

AFFIRM-1 Study Site

San Jose, California, United States

Site Status

AFFIRM-1 Study Site

Sherman Oaks, California, United States

Site Status

AFFIRM-1 Study Site

Temecula, California, United States

Site Status

AFFIRM-1 Study Site

Jacksonville, Florida, United States

Site Status

AFFIRM-1 Study Site

Lauderhill, Florida, United States

Site Status

AFFIRM-1 Study Site

Miami Lakes, Florida, United States

Site Status

AFFIRM-1 Study Site

Orlando, Florida, United States

Site Status

AFFIRM-1 Study Site

Tampa, Florida, United States

Site Status

AFFIRM-1 Study Site

Decatur, Georgia, United States

Site Status

AFFIRM-1 Study Site

Boston, Massachusetts, United States

Site Status

AFFIRM-1 Study Site

Boston, Massachusetts, United States

Site Status

AFFIRM-1 Study Site

Princeton, New Jersey, United States

Site Status

AFFIRM-1 Study Site

Brooklyn, New York, United States

Site Status

AFFIRM-1 Study Site

Charlotte, North Carolina, United States

Site Status

AFFIRM-1 Study Site

Media, Pennsylvania, United States

Site Status

AFFIRM-1 Study Site

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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https://theaffirm1study.com/

Study information and pre-screening portal for potential participants

Other Identifiers

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BNC210.014

Identifier Type: -

Identifier Source: org_study_id

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