Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)

NCT05030350 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: PH94B-CL030
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 3

Brief Summary

This study evaluates the safety and tolerability of PH94B with repeated dosing over a period of up to 12 months. Participating subjects will use PH94B up to 4 times a day when they encounter anxiety-provoking situations in daily life. Safety and tolerability of PH94B (≤ 4 doses per day up to 12 months) will be assessed and summarized during monthly visits from baseline (Visit 2) to end of treatment (Visit 14) in AEs, laboratory values, 12-lead ECGs, physical examinations, and vital sign assessments following exposure to PH94B.

Conditions

Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Subjects with at least one Serious Adverse Event (SAE)

  12 months

Other Outcomes (1)

• Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B

  V 2 (Baseline), V 3 (Month 1), V 4 (Month 2), V 5 (Month3), V 6 (Month 4), V 7 (Month 5), V 8 (Month 6), V 9 (Month 7), V 10 (Month 8), V11 (Month 9)

Study Arms (1)

PH94B 3.2 micrograms

EXPERIMENTAL

100 microliter nasal spray to each nostril up to four times a day as needed for acute anxiety

Drug: PH94B

Interventions

PH94B DRUG

Nasal spray

PH94B 3.2 micrograms

Eligibility Criteria

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

You may qualify if:

• Male and female adults, 18 through 65 years of age, inclusive.
• Women of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study, and must also have a negative urine pregnancy test result at both Screening (Visit 1) (for subjects who attend Visit 1) and Baseline (Visit 2), prior to IP administration. Effective methods of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
• Current diagnosis of social anxiety disorder
• Clinician-rated HAM-D17 total score \< 18 at study entry
• LSAS score 50 or greater

You may not qualify if:

• Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, autism-spectrum disorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
• Subjects who meet criteria for moderate or severe alcohol or substance use disorder within the 1 year prior to study entry.
• In the opinion of the Investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study.
• Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium.
• An acute or chronic condition, including an infectious illness, uncontrolled seasonal allergies at the time of the study, or significant nasal congestion that potentially could affect drug delivery to the nasal chemosensory epithelium.
• Subjects using the following psychotropic medications: anticonvulsants, mood stabilizers, antipsychotic medications, gabapentin, pregabalin, opioids, naltrexone, esketamine, and ketamine at enrollment.
• Subjects using lower doses of atypical antipsychotics at Screening may be eligible after discussion with the Medical Monitor (e.g., quetiapine \< 100 mg).
• In general, subjects using antidepressants or buspirone can continue to receive these provided that they have been taking them for a minimum of 2 months, and have been on a stable dose for a minimum of 1 month.
• Use of anxiolytics, such as benzodiazepines or unapproved treatments such as beta blockers, within 30 days before study entry; concomitant use is prohibited during the study. Subjects who have been taking benzodiazepines daily for 1 month or longer at the time of Visit 1 are not eligible to participate.
• Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
• Subjects with clinically significant abnormalities in hematology, blood chemistry, urinalysis, 12-lead ECG, or physical examination identified at the Screening visit or Baseline visit that in the clinical judgment of the Investigator, could place the subject at undue risk, interfere with study participation, or confound the results of the study.

Sponsors & Collaborators

• VistaGen Therapeutics, Inc.: lead

Study Sites (3)

VistaGen Investigational Site

Watertown, Massachusetts, 02472, United States

Location

VistaGen Investigational Site

New York, New York, 10128, United States

Location

VistaGen Investigational Site

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Ester Salman, MPH
• Organization: Vistagen Therapeutics, Inc.

clinicalstudies@vistagen.com

650-577-3693

Study Officials

• Jaakko Lappalainen, MD, PhD

  VistaGen Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: October 1, 2021
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)