Lead Sponsor

Engrail Therapeutics INC

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
•Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
•Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

•Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
•Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
•Reports moderately severe to severe symptoms of depression
•Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
•Recent suicidal ideation or behavior
•Current or recent moderate to severe substance use disorder as assessed by the MINI
•Clinically significant abnormal findings in safety assessments
•Has significant progressive disorders or unstable medical conditions
•Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

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