Randomized Trial of a Single Injection of RE104 Versus Placebo for Generalized Anxiety Disorder

What this Trial Is About

Researchers are evaluating a single injection of RE104 for Injection to see if it reduces anxiety symptoms in adults with Generalized Anxiety Disorder GAD. This Phase 2 trial compares the effects of RE104 against a placebo in a randomized, double-blind, placebo-controlled setting to understand its impact on anxiety levels. Participants receive either a single subcutaneous injection of 30 mg RE104 or a placebo 0.9% sodium chloride during the study. The trial uses a parallel design where each participant is randomly assigned to one of the two groups. The main treatment effect is measured at 4 weeks after dosing, and follow-up assessments continue up to 12 weeks to monitor anxiety symptoms and any adverse events. During the study, participants will undergo evaluations including the Hamilton Anxiety Rating Scale HAM-A and Hospital Anxiety and Depression Scale HADS at multiple time points. Researchers will assess changes in anxiety scores, response rates, remission rates, and safety by monitoring treatment-emergent adverse events. The total follow-up after dosing lasts 12 weeks, with scheduled assessments at weeks 1, 2, 4, 8, and 12 to track progress and safety.

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder