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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 225 mg BNC210 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 225 mg BNC210 | Drug | 225 mg BNC210 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation 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: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AFFIRM-1 Study Site | Encino | California | 91316 | United States | ||
| AFFIRM-1 Study Site |
Not provided
| Label | URL |
|---|---|
| Study information and pre-screening portal for potential participants | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 225 mg BNC210 | 225 mg BNC210 Single Dose |
| FG001 | Placebo | Placebo Single Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2024 | Mar 7, 2026 |
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| Drug |
Placebo |
|
| Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score | The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity. | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
| Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score | The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity. | Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
| Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety. | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
| La Jolla |
| California |
| 92037 |
| United States |
| AFFIRM-1 Study Site | Los Angeles | California | 90025 | United States |
| AFFIRM-1 Study Site | Oceanside | California | 92056 | United States |
| AFFIRM-1 Study Site | San Diego | California | 92103 | United States |
| AFFIRM-1 Study Site | San Jose | California | 95124 | United States |
| AFFIRM-1 Study Site | Sherman Oaks | California | 91403 | United States |
| AFFIRM-1 Study Site | Temecula | California | 92591 | United States |
| AFFIRM-1 Study Site | Jacksonville | Florida | 32256 | United States |
| AFFIRM-1 Study Site | Lauderhill | Florida | 33319 | United States |
| AFFIRM-1 Study Site | Miami Lakes | Florida | 33016 | United States |
| AFFIRM-1 Study Site | Orlando | Florida | 32801 | United States |
| AFFIRM-1 Study Site | Tampa | Florida | 33607 | United States |
| AFFIRM-1 Study Site | Decatur | Georgia | 30030 | United States |
| AFFIRM-1 Study Site | Boston | Massachusetts | 02114 | United States |
| AFFIRM-1 Study Site | Boston | Massachusetts | 02131 | United States |
| AFFIRM-1 Study Site | Princeton | New Jersey | 08540 | United States |
| AFFIRM-1 Study Site | Brooklyn | New York | 11229 | United States |
| AFFIRM-1 Study Site | Charlotte | North Carolina | 28211 | United States |
| AFFIRM-1 Study Site | Media | Pennsylvania | 19063 | United States |
| AFFIRM-1 Study Site | Austin | Texas | 78737 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 225 mg BNC210 | 225 mg BNC210 Single Dose |
| BG001 | Placebo | Placebo Single Dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Liebowitz Social Anxiety Scale (LSAS) | The Liebowitz Social Anxiety Scale (LSAS) is a clinician administered rating scale used for the quantification of symptomatic distress and impairment caused by social anxiety disorder (SAD). The scale includes 24 items divided into two subscales (fear or anxiety, and avoidance) that evaluate social, interactional and performance situations. Scores on each of the items are added to give a global score ranging from 0-144, with higher scores indicating greater severity of SAD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Performance Phase conducted at 65 to 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
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| Secondary | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and during the Public Speaking Challenge Anticipation Phase conducted at 60 to 62 minutes post-dose (the first 2 minutes of the Public Speaking Challenge). |
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| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Clinical Global Impressions-Severity (CGI-S) Score | The CGI-S measures overall disease severity of the participant's symptoms as scored by a clinician. Severity is rated from 1 (normal, not at all ill) to 7 (among the most extremely ill of patients) with a higher score indicating a higher level of disease severity. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
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| Secondary | Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score | The PGI-I is a patient self-reported counterpart of the CGI designed to assess the patient's impression of their perceived change in overall symptoms. Improvement is rated from 1 (very much improved) to 7 (very much worse) with a higher score indicating a higher level of disease severity. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: On the treatment day at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
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| Secondary | Change From Baseline to the End of the 5-minute Performance Phase of a Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score | The State-Trait Anxiety Inventory (State component; STAI-State) is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: On the treatment day at Baseline (approximately 5 minutes pre-dose) and at the end of the Public Speaking Challenge Performance Phase at 70 minutes post-dose (following the Anticipation Phase that started at 60 min). |
|
|
1 week
2 participants in the 225 mg BNC210 group and 1 participant in the placebo group did not receive study drug and therefore were not included in the safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 225 mg BNC210 | 225 mg BNC210 Single Dose | 0 | 183 | 0 | 183 | 23 | 183 |
| EG001 | Placebo | Placebo Single Dose | 0 | 184 | 0 | 184 | 9 | 184 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP Clinical Development | Bionomics Limited | +1 (781) 730 6665 | bnc210clinicalstudies@bionomics.com.au |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2025 | Mar 7, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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