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

NCT04045678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-22

No results posted yet for this study

Summary

This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.

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.

Sponsors & Collaborators

  • Beijing Bozhiyin T&S Co., Ltd.

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2019-04-16
Completion
2019-06-21

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045678 on ClinicalTrials.gov