drugset / Trial / NCT02055274

Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease

NCT02055274

Phase 1 Completed 39 enrolled Luye Pharma Group Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003 following intramuscular injections.

Timeline

Start
2013-10
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject LY03003 Unknown 14 mg Intramuscular
Subject LY03003 Unknown 28 mg Intramuscular
Subject LY03003 Unknown 42 mg Intramuscular
Subject LY03003 Unknown 56 mg Intramuscular
Comparator Rotigotine Unknown 6 mg Other
Comparator Rotigotine Unknown 8 mg Other

Indications