Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

NCT06693609 | Completed Phase 2

• 1 other identifier: EMP-01-201
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief Summary

This Phase 2 study (protocol number EMP-01-201) will determine the safety and tolerability of a short-term treatment with an oral dosage form of EMP-01 in adult participants with social anxiety disorder (SAD) and will assess exploratory efficacy of repeated doses of EMP-01 versus placebo.

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of treatment emergent adverse events, adverse events of special interest and serious adverse events.

  Assess the safety and tolerability of EMP-01 compared with placebo (PBO) in participants with SAD.

  Day 1 to EOS [Day 43]

• Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results.

  Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.

  Day 1 [post-dose] to Day 57

• Columbia-Suicide Severity Rating Scale (C-SSRS) Score

  Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.

  Baseline to Day 57

Secondary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  Baseline to EOS [Day 43]

Study Arms (2)

EMP-01

EXPERIMENTAL

Drug: EMP-01

EMP-01 Placebo

PLACEBO COMPARATOR

Drug: EMP-01 Placebo

Interventions

EMP-01 DRUG

EMP-01 capsules

EMP-01

EMP-01 Placebo DRUG

EMP-01 placebo capsules

EMP-01 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility will be assessed at Screening and will be reconfirmed on Day -1 (Baseline) based on available information, before randomization on the following day (Day 1).
• Participants must meet all of the following criteria to be enrolled in this study:
• Age
• Participants must be between 18 and 65 years of age, inclusive, at the time of signing the ICF.
• Disease Characteristics
• Has a current diagnosis of SAD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), which is not better attributable to another psychiatric condition or to a medical condition. The diagnosis will be confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• Clinician-administered LSAS total score ≥ 70 at Screening and Day -1.
• Clinician Global Impressions - Severity (CGI-S) score ≥ 4 at Screening and Day-1.
• Weight
• Body mass index (BMI) within the range 20-34 kg/m2 (inclusive) at Screening.
• Able (in the investigator's opinion) to comprehend and be willing to sign an ICF, to abide by the study restrictions, and to attend all study visits.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from this study:
• Medical Conditions
• Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features (including MDD with psychotic features), as assessed by medical history and a structured clinical interview (MINI).
• Has a current DMS-5-TR diagnosis of SAD performance only sub-type, PTSD, acute stress disorder, anorexia nervosa, bulimia nervosa, or any other co-morbid psychiatric condition that dominates the clinical presentation and would interfere with experimental treatment.
• Has a current DMS-5-TR disorder, other than SAD, which is the primary focus of treatment. Note that participants with concurrent GAD are eligible for the study, provided that GAD is not the primary diagnosis. Participants with attention deficit hyperactivity disorder (ADHD) are eligible for the study, provided that they do not require pharmacological treatment for the condition AND if ADHD is not the primary diagnosis.
• Has severe current depression, as measured by a total score ≥ 16 on the QIDS-SR-16.
• Has a history of moderate or severe alcohol or cannabis use disorder within 1 year before Screening. Has any severity (including mild) of other substance use disorder (drug) within 1 year before Screening, as confirmed by the MINI.
• Has had suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.

Sponsors & Collaborators

• atai Therapeutics, Inc.: lead
• EmpathBio, Inc.: collaborator

Study Sites (7)

MAC Clinical Research - South Staffordshire

Bridgetown, Cannock, Staffordshire, S75 3DL, United Kingdom

Location

MAC Clinical Research - Greater Manchester

Manchester, Greater Manchester, M13 9NQ, United Kingdom

Location

MAC Clinical Research - Lancashire

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

MAC Clinical Research - Merseyside

Liverpool, Merseyside, L34 1BH, United Kingdom

Location

MAC Clinical Research - South Yorkshire

Tankersley, South Yorkshire, S75 3DL, United Kingdom

Location

MAC Clinical Research - Teesside

Thornaby, Stockton-on-Tees, TS17 6EW, United Kingdom

Location

MAC Clinical Research Centre, West Yorkshire

Leeds, LS10 1DU, United Kingdom

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: April 15, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)