NCT05193409

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Bionomics Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	225 mg BNC210	225 mg BNC210
DRUG	675 mg BNC210	675 mg BNC210
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-10-10
• Completion: 2022-10-17
• First posted: 2022-01-14
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study