A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of GT-02287 in Healthy Participants - Trial ANZCTR12623000860662

Timeline & Enrollment

Primary Outcome

To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of the Incidence, nature, and severity of all adverse events (AEs) from Screening to Follow-up visit, including time of onset/offset from administration of GT 02287.;; To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of the Incidence of clinically significant findings for: - Clinical laboratory evaluations (hematology, coagulation, biochemistry, and urinalysis) - Physical and neurological examinations - Vital signs measurements (tympanic temperature, resting pulse, and resting pressure [BP]) - 12-lead electrocardiograms (ECGs);; To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of Questionnaires: Bond and Lader Visual Analogue Scale (BL-VAS), Profile of Mood States Short Form (POMS-SF) and Columbia Suicide Severity Rating Scale (C SSRS).

Summary

This phase 1 study is a randomized, placebo-controlled, double-blind, trial of an oral drug called GT 02287 vs. placebo in healthy volunteers. The study will assess the safety, tolerability, Pharmacokinetics, and Food Effect in single and multiple ascending dose cohorts.

ICD-10 Classifications