PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of
the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects
with social anxiety disorder (SAD) during an induced public speaking challenge.
Subject participation in the Study will last a total of 3 to 7 weeks, depending on the
duration of the screening period and intervals between visits. Upon signing an informed
consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting
between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening
period, subjects will return for Visit 2 and self-administer the nasal spray and then
participate in a 5 minute public speaking challenge. During the public speaking challenge,
the subject will be asked for their anxiety score, which will be recorded by a trained
observer. At Visit 3, the subjects will undergo the same public speaking procedure once again
as they did in Visit 2. One week after the completion of the Visit 3 public speaking
challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of
the safety and psychiatric assessments conducted at Screening.