drugset / Trial / NCT05321602

Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder

NCT05321602

Phase 1 Completed 89 enrolled Luye Pharma Group Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.

Timeline

Start
2021-09-08
Primary completion
2022-09-23
Completion
2022-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject LY03010 Unknown 156 mg Intramuscular
Subject LY03010 Unknown 351 mg Intramuscular