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| Name | Class |
|---|---|
| Beijing Bozhiyin T&S Co., Ltd. | INDUSTRY |
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This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03003 ( Rotigotine, extended-release microspheres) | Drug | Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks. Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Adverse events to evaluate the safety and tolerability of LY03003 | From screening up to day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration (Tmax) of total LY03003 | From the first injection of stable doses up to day 50 | |
| Maximum concentration in plasma (Cmax) of total LY03003 | From the first injection of stable doses up to day 50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | China | ||||
| Xuanwu Hospital Capital Medical University |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Placebo, extended-release microspheres | Drug | Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks. Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks. |
|
| Area under the concentration-time curve (AUC) from zero up to the last measured concentration [AUC (0-t)] of LY03003 | From the first injection of stable doses up to day 50 |
| Area under the concentration-time curve (AUC) from time zero up to the infinite time [AUC (0-∞)] of LY03003 | From the first injection of stable doses up to day 50 |
| Apparent volume of distribution (Vd) of LY03003 | From the first injection of stable doses up to day 50 |
| Terminal half-life (t1/2) of total LY03003 | From the first injection of stable doses up to day 50 |
| Total body clearance of LY03003 | From the first injection of stable doses up to day 50 |
| Maximum steady-state drug concentration of LY03003 | From the first injection of stable doses up to day 50 |
| Minimum steady-state drug concentration of LY03003 | From the first injection of stable doses up to day 50 |
| Average steady-state concentration of LY03003 | From the first injection of stable doses up to day 50 |
| Area under the concentration-time curve (AUC) at steady-state concentration of LY03003 | From the first injection of stable doses up to day 50 |
| Fluctuation degree in steady-state concentration of LY03003 | From the first injection of stable doses up to day 50 |
| Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅱ+Ⅲ) Total Score | The Unified Parkinson´s Disease Rating Scale Part Ⅱ measures "Activities in Daily Living". The total score ranges from 0 (Best score possible) to 52 (Worst score possible). The Unified Parkinson´s Disease Rating Scale Part Ⅲ is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108. | Screening, baseline, days 29 and day 50 |
| Beijing |
| China |
| Shengjing Hospital of China Medical University | Shenyang | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |