Phase 1 Study of LY03020 Oral Tablets to Assess Safety, Tolerability, and Pharmacokinetics in Chinese Adults with Stable Schizophrenia or Healthy Volunteers

What this Trial Is About

Researchers are studying LY03020, an oral drug, to understand its safety, tolerability, and how it is processed by the body in healthy Chinese adults and adults with stable schizophrenia. This randomized, double-blind, placebo-controlled Phase 1 study aims to carefully evaluate these factors in both healthy participants and those with stable schizophrenia, including assessments of side effects and drug levels in the blood. Participants will be randomly assigned to receive either LY03020 or a placebo once daily from Day 1 to Day 7. The study includes close monitoring during this treatment period to observe effects and collect blood samples for pharmacokinetic analyses. The design includes multiple dose levels to assess how the drug behaves at different dosages. Throughout the study, participants will undergo various evaluations including safety monitoring for adverse events, vital signs, ECGs, and eye exams. For those with schizophrenia, mental health assessments like the Positive and Negative Syndrome Scale PANSS and suicide severity rating will be conducted. The study lasts up to Day 11 after dosing begins, allowing researchers to monitor participants closely for any changes or side effects.

A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020