Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Intra-Cellular Therapies (ITCI) is the sponsoring company for this trial. BiotechSign currently grades this company C (63/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.