NCT06980207

A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral LPM526000133 Fumarate Capsules (LY03017) in Healthy Adult Subjects.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1，randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects

Detailed description

Primary: To assess the safety and tolerability of multiple oral doses of LY03017 in healthy adult subjects. Secondary: To assess the pharmacokinetics (PK) of LY03017 after multiple oral doses of LY03017 in healthy adult subjects.

Conditions

• Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis
• Hallucinations and Delusions Associated With Parkinson Disease Psychosis
• Negative Symptoms of Schizophrenia

Interventions

Type	Name	Description
DRUG	LY03017	administered orally
DRUG	LY03017-Placebo	administered orally

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: China