Home›Trial›NCT06557902
🔬NCT06557902Phase 1RECRUITING

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Study Summary

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.

Conditions
Autism Spectrum Disorder
Interventions / Drugs
Lumateperone 10.5 mg capsuleLumateperone 21 mg capsuleLumateperone 5 mg ODTLumateperone 10.5 mg ODTLumateperone 15.5 mg ODTLumateperone 21 mg ODT
View on ClinicalTrials.gov ↗
Sponsor
ITCI
Intra-Cellular Therapies
Neuroscience
F29/100
Study Details
Enrollment26 participants
Primary Completion—
Lead SponsorIntra-Cellular Therapies, Inc.
Data Retrieved2026-04-11 04:18:13.264785+00:00
Not financial advice. BiotechSigns data is sourced from ClinicalTrials.gov, SEC EDGAR, and other public databases for research and informational purposes only. It does not constitute investment recommendations. Always do your own due diligence before making investment decisions.