A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 5, 2018

Primary Completion Date

March 14, 2019

Study Completion Date

March 14, 2019

Conditions
Parkinson Disease
Interventions
DRUG

LY03003

Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.

DRUG

Placebo

Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.

Trial Locations (1)

Unknown

Shengjing Hospital of China Medical University, Shenyang

All Listed Sponsors
lead

Luye Pharma Group Ltd.

INDUSTRY

NCT04629404 - A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients | Biotech Hunter | Biotech Hunter