Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder
Research type
Research Study
Full title
A Phase 2a, Exploratory, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, and Efficacy of EMP-01 in Adult Participants with Social Anxiety Disorder
IRAS ID
1010893
Contact name
Odette Hauke
Contact email
Sponsor organisation
EmpathBio Inc.
Research summary
Social anxiety disorder (SAD), is a mental health disorder characterized by intense fear of social situations. The symptoms of SAD also include both physical effects (e.g. sweating, nausea) and psychological effects (e.g. excessive worrying, avoidance and low self-esteem). People with social anxiety disorder might avoid social gatherings, public speaking, or even everyday interactions like talking to strangers or making eye contact. As a result, people with SAD may experience social isolation and loneliness, with people missing out on meaningful experiences, friendships and opportunities. Currently, the most used medications for SAD are antidepressants, which may only help with some of the symptoms and not in all patients with SAD. Therefore, more treatment options for SAD are needed.
This study is a placebo-controlled trial, meaning that participants will be either given the active drug or an inactive placebo to compare the active drug effects. The study will enroll approximately 60 participants with a current SAD diagnosis. Participants will be randomly assigned to study groups in a 1:1 manner, meaning they will have a 50 % chance of being assigned to either active treatment or placebo. Neither the participants nor the researchers know who is receiving the actual treatment.
The purpose of this study is to test a drug called EMP-01 that is being developed for the treatment of SAD. Eligible participants between 18 and 65 years who have a current diagnosis of SAD, will be enrolled into the trial. The participants will receive either 225 mg of EMP-01 or placebo, at two different time points with a 4-week gap between doses (Day 1 and Day 29).
The primary endpoint for the study will be assessed 2 weeks after receiving the second EMP-01 or placebo dose (Day 43). Participants will be monitored for safety and to estimate the changes in their SAD and related symptoms will be assessed 2 weeks after EMP-01 or placebo dose (Day 43). ).REC name
Wales REC 1
REC reference
24/WA/0327
Date of REC Opinion
2 Jan 2025
REC opinion
Further Information Favourable Opinion