Safety, Tolerability and Efficacy of RGH-202 in Social Anxiety Disorder (STAGE)

Ki vehet részt

• Adults aged 18 to 65 years
• Otherwise healthy participants without clinically significant medical abnormalities
• Primary DSM-5-TR diagnosis of Social Anxiety Disorder (SAD), confirmed by structured diagnostic interview
• Body weight ≥40 kg and BMI 18.5-36.6 kg/m²
• Participants of reproductive potential must agree to protocol-defined contraception requirements; women of childbearing potential must have negative pregnancy testing
• Able and willing to provide informed consent
• Able to understand study procedures and comply with study requirements
• LSAS total score ≥70 at Screening and Baseline
• Fluent in English and able to complete study assessments
• Able to swallow oral capsules

Ki nem vehet részt

• Moderate to severe alcohol use disorder or substance use disorder within the previous 12 months
• Recent or ongoing treatment with anxiolytics, including benzodiazepines
• Recent or ongoing treatment with antidepressants, antipsychotics, mood stabilizers, stimulants, anticonvulsants, acetylcholinesterase inhibitors, or other psychotropic medications
• Recent use of medications or substances used to treat anxiety symptoms
• Concomitant medications that may interfere with study participation or interpretation
• Use of medications that significantly affect CYP metabolism or drug disposition
• Recent use of strong CYP2D6 inhibitors
• Use of medications that are sensitive CYP3A4 substrates
• Participation in neuromodulation therapy
• Participation in another interventional clinical trial within the previous 3 months
• Positive drug screen or cannabis use
• Medical condition or prior surgery that may affect drug absorption
• Current primary psychiatric disorder other than SAD
• History of schizophrenia spectrum disorder, bipolar disorder, clinically significant personality disorder, or other psychiatric conditions judged likely to interfere with study participation
• Current OCD, PTSD, panic disorder, or eating disorder
• Any clinically significant medical or psychiatric condition that may increase risk or interfere with study participation
• Clinically significant cardiac conduction abnormalities
• Family history of seizures
• History of seizure disorder or conditions associated with increased seizure risk
• Clinically significant chronic neurological disorder or chronic pain condition
• Current or chronic clinically significant liver disease
• Current psychotherapy specifically targeting social anxiety disorder
• Positive HIV, hepatitis B, or hepatitis C test
• Known hypersensitivity to study medication or excipients
• Clinically significant abnormal medical history, examination, laboratory, or ECG findings
• Moderate to severe renal impairment (eGFR <50 mL/min)
• Family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death
• Clinically significant QTc prolongation
• Clinically significant laboratory abnormalities
• ALT, AST, or ALP >2× ULN
• Total bilirubin >1.5× ULN
• Use of medications known to prolong QT interval
• MADRS score ≥24
• Current suicidal ideation, recent suicidal ideation, or lifetime suicide attempt
• Clinically significant abnormal vital signs
• Use of herbal or dietary supplements or recent initiation of herbal supplements with known hepatotoxic potential
• Positive alcohol test at screening or baseline
• Positive pregnancy test
• Current excessive alcohol consumption
• Lactation or breastfeeding