NCT04044547

A Study of LY03003 in Patients With Early-stage Parkinson's Disease

A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Rotigotine, extended-release microspheres	Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule: * Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks. * Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks. * Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks. * Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.
DRUG	Placebo, extended-release microspheres	Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule: * Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks. * Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks. * Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks. * Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks.

Timeline

• Start date: 2013-11-22
• Primary completion: 2014-02-26
• Completion: 2015-06-11
• First posted: 2019-08-05
• Last updated: 2019-08-05