This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
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.
Chinese PLA General Hospital
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Shengjing Hospital of China Medical University
Shenyang, China
Frequency of adverse events
Adverse events to evaluate the safety and tolerability of LY03003
Time frame: From screening up to day 50
Time of maximum concentration (Tmax) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Maximum concentration in plasma (Cmax) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) from zero up to the last measured concentration [AUC (0-t)] of LY03003
Time frame: 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
Time frame: From the first injection of stable doses up to day 50
Apparent volume of distribution (Vd) of LY03003
Time frame: From the first injection of stable doses up to day 50
Terminal half-life (t1/2) of total LY03003
Time frame: From the first injection of stable doses up to day 50
Total body clearance of LY03003
Time frame: From the first injection of stable doses up to day 50
Maximum steady-state drug concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Minimum steady-state drug concentration of LY03003
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Time frame: From the first injection of stable doses up to day 50
Average steady-state concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Area under the concentration-time curve (AUC) at steady-state concentration of LY03003
Time frame: From the first injection of stable doses up to day 50
Fluctuation degree in steady-state concentration of LY03003
Time frame: 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.
Time frame: Screening, baseline, days 29 and day 50