Gedeon Richter Plc.
The reason for this trial is to see if the investigational product, called RGH-202, is safe and well tolerated, and can help people with social anxiety disorder. The main questions this study aims to answer are: * Is RGH-202 safe and well tolerated in adults with social anxiety disorder? * Does RGH-202 reduce symptoms of social anxiety disorder compared with placebo? RGH-202 will be compared with a placebo (a product that does not contain any active ingredients) to determine whether the investigational medicine may be an effective treatment for SAD. Participants will have an equal chance of receiving RGH-202 or the placebo taken for 6 weeks. Participants will attend regular clinic visits for safety assessments, study evaluations and complete questionnaires related to their social anxiety symptoms.
Inclusion criteria: * 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 sc…
Oral capsule dosage form applied once daily for 42 days
Oral capsule dosage form applied once daily for 42 days