NCT07230652

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

A Randomized, Double-Blind, Placebo-Controlled, Dose- Ascending Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Chinese Adult Healthy Subjects and/or Subjects With Stable Schizophrenia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.

Conditions

• Schizophrenia
• Alzheimer's Disease Psychosis

Interventions

Type	Name	Description
DRUG	LY03020	administered orally
DRUG	Placebo	administered orally

Timeline

• Start date: 2025-08-20
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2025-11-17
• Last updated: 2025-11-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study