Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of
RLS103 (cannabidiol [CBD] inhaled dry powder) to relieve the anxiety induced by a public
speaking challenge in adults with social anxiety disorder (SAD).
Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects
will enter a screening phase lasting up to 3 weeks and including history, physical
examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will
undergo a public speaking test after screening tests are performed and eligibility is
confirmed. One week after the completion of the public speaking test, subjects will come back
for a follow-up visit that will involve a repeat of the safety and psychiatric assessments
conducted during screening.