A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 10, 2017

Primary Completion Date

April 16, 2019

Study Completion Date

June 21, 2019

Conditions
Parkinson Disease
Interventions
DRUG

LY03003 ( Rotigotine, extended-release microspheres)

"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."

DRUG

Placebo, extended-release microspheres

"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."

Trial Locations (3)

Unknown

Chinese PLA General Hospital, Beijing

Xuanwu Hospital Capital Medical University, Beijing

Shengjing Hospital of China Medical University, Shenyang

All Listed Sponsors
collaborator

Beijing Bozhiyin T&S Co., Ltd.

INDUSTRY

lead

Luye Pharma Group Ltd.

INDUSTRY

NCT04045678 - A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease | Biotech Hunter | Biotech Hunter