This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
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.
LY03003 concentration in plasma
Time frame: Days 1, 2, 4, 6, 8, 15, 22, 29, 30, 32, 34, 36, 38, 40, 43, and day 50
Frequency of adverse events
Adverse events to evaluate the safety and tolerability of LY03003
Time frame: From screening up to day 50
Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale (UPDRS) part (Ⅲ) Total Score
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 (Best score possible) to 108 (Worst score possible).
Time frame: screening, baseline and day 29 and Day 50
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