PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2

Inclusion Criteria:

1. Written informed consent provided prior to conducting any study-specific assessment.
2. Male and female adults, 18 through 65 years of age, inclusive.
3. Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of MentalDisorders, 5th Edition, and confirmed by the MINI.
4. Clinician-rated LSAS total score ≥70 at Screening (Visit 1).
5. Clinician-rated Hamilton Depression Score 17-items total score <18 at Screening (Visit 1).
6. Women of childbearing-potential must be able to commit to the consistent and correctuse of an effective method of birth control throughout the study, and must also have anegative urine pregnancy test result at both Screening (Visit 1) and Baseline (Visit 2), prior to investigational product (IP) administration. Effective methods ofcontraception include: condoms with spermicide, diaphragm with spermicide, hormonalcontraceptive agents (oral, transdermal, or injectable), or implantable contraceptivedevices.
7. Negative COVID-19 test either in the presence of COVID-19 symptoms or after directexposure to someone with a positive COVID-19 test

Exclusion Criteria:

1. Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder,psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrumdisorder, or obsessive-compulsive disorder. Any other current Axis I disorder, other than SAD, which is the primary focus oftreatment. Note that subjects with concurrent Generalized Anxiety Disorder areeligible for the study provided that Generalized Anxiety Disorder is not the primarydiagnosis.
2. Subjects who meet criteria for moderate or severe alcohol or substance use disorderwithin the 1 year prior to Study entry.
3. In the opinion of the investigator, the subject has a significant risk for suicidalbehavior during the course of their participation in the study, or
4. At Screening (Visit 1): the subject scores "yes" on items 4 or 5 in the SuicidalIdeation section of the Columbia-Suicide Severity Rating Scale (C SSRS) withreference to a 6-month period prior to screening; or
5. At Screening (Visit 1): the subject has had 1 or more suicidal attempts withreference to a 2 year period prior to screening; or
6. At Baseline (Visit 2): the subject scores "yes" on items 4 or 5 in the SuicidalIdeation section of the C-SSRS with reference to screening; or
7. The subject is considered to be an imminent danger to themself or others.
8. Clinically significant nasal pathology or history of significant nasal trauma, nasalsurgery, total anosmia, or nasal septum perforation that may have damaged the nasalchemosensory epithelium.
9. An acute or chronic condition, including an infectious illness, uncontrolled seasonalallergies at the time of the study, or significant nasal congestion that potentiallycould affect drug delivery to the nasal chemosensory epithelium.
10. Two or more documented failed treatment trials with a registered medication approvedfor SAD, at any time during the lifetime of the subject, whereby an adequate treatmenttrial is defined as that described in the package insert for a particular drug duringwhich the subject received an adequate medication dosage (defined as the treatmentdose indicated in the package insert to obtain efficacy for that particular drug).
11. Use of any psychotropic medication within 30 days before study entry (other thanmedication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon,zolpidem, or antihistamines).
12. Use of any anxiolytics, such as benzodiazepines or unapproved treatments such as betablockers, within 30 days before study entry; concomitant use is prohibited during thestudy. Subjects who have been taking benzodiazepines daily for 1 month or longer atthe time of Visit 1 are not eligible to participate.
13. Use of any over-the-counter product, prescription product, or herbal preparation fortreatment of the symptoms of anxiety or social anxiety within 30 days before studyentry; concomitant use is prohibited during the study.
14. Prior participation in a clinical trial involving PH94B.
15. Women who have a positive urine pregnancy test prior to IP administration.
16. Subjects with clinically significant abnormalities in hematology, blood chemistry,urinalysis, electrocardiogram, or physical examination identified at the Screeningvisit or Baseline visit that in the clinical judgment of the Investigator, could placethe subject at undue risk, interfere with study participation, or confound the resultsof the study.