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

NCT05030350 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2025-10-21

Study results available
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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

Interventions

DRUG

PH94B

Nasal spray

Sponsors & Collaborators

  • VistaGen Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaakko Lappalainen, MD, PhD · VistaGen Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-09-23
Completion
2022-09-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030350 on ClinicalTrials.gov