Tryptamine Therapeutics (ASX:TYP) received approval from the Swinburne University Human Research Ethics Committee to initiate an open-label study to assess the safety and efficacy of TRP-8803 in combination with psychotherapy in adult patients with binge eating disorder, according to a Monday filing with the Australian bourse.
The main goal of the trial is to determine the safety and effectiveness of two TRP-8803 doses over a 12-week follow-up period after the second dose.
TRP-8803 is a psilocin-based intravenous-infusion formulation with potential neuroplastic benefits, the filing said.
The trial will administer two doses of TRP-8803 to 12 participants in two patient cohorts, 14 days apart.
Secondary and exploratory objectives include assessing TRP-8803's ability to induce a psychedelic state and its impact on binge-eating frequency and other weight-related measures at both four and 12 weeks post-second dosing, per the filing.