MedTrace Logo

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

NCT04629404 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-11-16

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2019-03-14
Completion
2019-03-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04629404 on ClinicalTrials.gov