Trial Outcomes & Findings for Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1 (NCT NCT06510504)
NCT ID: NCT06510504
Last Updated: 2026-05-19
Results Overview
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
COMPLETED
PHASE3
370 participants
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).
2026-05-19
Participant Flow
Participant milestones
| Measure |
225 mg BNC210
225 mg BNC210 Single Dose
|
Placebo
Placebo Single Dose
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
185
|
|
Overall Study
COMPLETED
|
183
|
183
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Baseline characteristics by cohort
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
Total
n=370 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 Years
STANDARD_DEVIATION 12.62 • n=30 Participants
|
36.1 Years
STANDARD_DEVIATION 12.12 • n=30 Participants
|
36 Years
STANDARD_DEVIATION 12.36 • n=60 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=30 Participants
|
112 Participants
n=30 Participants
|
232 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=30 Participants
|
73 Participants
n=30 Participants
|
138 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=30 Participants
|
34 Participants
n=30 Participants
|
72 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
142 Participants
n=30 Participants
|
150 Participants
n=30 Participants
|
292 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=30 Participants
|
39 Participants
n=30 Participants
|
68 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=30 Participants
|
40 Participants
n=30 Participants
|
80 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=30 Participants
|
92 Participants
n=30 Participants
|
189 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
|
Liebowitz Social Anxiety Scale (LSAS)
|
93.5 units on a scale
STANDARD_DEVIATION 15.79 • n=30 Participants
|
96.9 units on a scale
STANDARD_DEVIATION 17.94 • n=30 Participants
|
95.2 units on a scale
STANDARD_DEVIATION 16.96 • n=60 Participants
|
PRIMARY outcome
Timeframe: 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).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
Outcome measures
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
|---|---|---|
|
Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
|
27.2 score on a scale
Interval 23.8 to 30.5
|
26.0 score on a scale
Interval 22.6 to 29.3
|
SECONDARY outcome
Timeframe: 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).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.
Outcome measures
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
|---|---|---|
|
Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
|
13.3 score on a scale
Interval 10.2 to 16.5
|
14.1 score on a scale
Interval 11.0 to 17.3
|
SECONDARY outcome
Timeframe: 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).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.
Outcome measures
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
|---|---|---|
|
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
|
1.21 score on a scale
Interval 1.03 to 1.39
|
1.06 score on a scale
Interval 0.88 to 1.23
|
SECONDARY outcome
Timeframe: 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).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.
Outcome measures
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
|---|---|---|
|
Difference at the End of the 5-minute Performance Phase of a Public Speaking Challenge in the Patient Global Impressions-Improvement (PGI-I) Score
|
3.74 score on a scale
Interval 3.52 to 3.95
|
3.82 score on a scale
Interval 3.61 to 4.03
|
SECONDARY outcome
Timeframe: 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).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.
Outcome measures
| Measure |
225 mg BNC210
n=185 Participants
225 mg BNC210 Single Dose
|
Placebo
n=185 Participants
Placebo Single Dose
|
|---|---|---|
|
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
|
4.37 score on a scale
Interval 2.71 to 6.04
|
3.65 score on a scale
Interval 2.0 to 5.3
|
Adverse Events
225 mg BNC210
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
225 mg BNC210
n=183 participants at risk
225 mg BNC210 Single Dose
|
Placebo
n=184 participants at risk
Placebo Single Dose
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
2.7%
5/183 • 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.
|
1.1%
2/184 • 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.
|
|
Nervous system disorders
Headache
|
4.9%
9/183 • 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.
|
1.6%
3/184 • 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.
|
|
Nervous system disorders
Somnolence
|
4.9%
9/183 • 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.
|
2.2%
4/184 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place