NCT06556966

A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects

A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.

Detailed description

The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.

Conditions

• Schizophrenia
• Alzheimer's Disease Psychosis

Interventions

Type	Name	Description
DRUG	LY03020	LY03020 for one single dose
DRUG	Placebo	Placebo for one single dose

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-02-13
• Completion: 2025-02-13
• First posted: 2024-08-16
• Last updated: 2025-05-29

Locations

1 site across 1 country: China