Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03003 | Experimental | 4 Stable doses of LY03003 14, 28, 42 and 56 mg |
|
| Neupro | Active Comparator | Neupro patch 2 mg/24 hours in the first week, and then be titrated to 4, 6 and 8 mg/24 hours at weekly intervals |
|
| Neupro PK | Active Comparator | Neupro patch 2 mg/24hr in the first week then titrated to 4 and 6mg/24hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03003 | Drug |
| ||
| Neupro |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for the Pharmacokinetics (PK) of LY03003 | 5 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 5 Weeks | |
| Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III) | 5 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon Li | Luye Pharma Group Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network LLC | Long Beach | California | 90806 | United States | ||
| Compass Research LLC |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C047508 | rotigotine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Orlando |
| Florida |
| 32806 |
| United States |
| West Georgia Sleep Disorders Center and Neurology Associates | Douglasville | Georgia | 30134 | United States |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | United States |
| PRA - CRI Lifetree | Marlton | New Jersey | 08053 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |