NCT04629404

A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	LY03003	Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.
DRUG	Placebo	Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-03-14
• Completion: 2019-03-14
• First posted: 2020-11-16
• Last updated: 2020-11-16

Locations

1 site across 1 country: China