Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

Summary

This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.

Timeline

Start

2021-10-01

Primary completion

2022-09-23

Completion

2022-09-23

Outcome

Outcome not reported

Stopped (Business): “Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B”

Drugs

Indications