NCT05429788

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

A Phase 1b/2a Randomized, Double-Blind, Placebo Controlled, Parallel Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (CBD Technosphere® Inhalation Powder) in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Receptor Life Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Low dose RLS103	3 mg CBD inhaled powder administered before public speaking challenge
DRUG	High dose RLS103	6 mg CBD inhaled powder administered before public speaking challenge
DRUG	placebo inhaled dry powder	placebo inhaled powder administered before public speaking challenge

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2022-06-23
• Last updated: 2024-04-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study