Clinical Trials Logo
  1. Home
  2. Parkinson's Disease
  3. NCT04593511

to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers

Parkinson's Disease Clinical Trial

Official title:
An Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular Injection

Clinical Trial Summary

The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.

Clinical Trial Description

This is an open-label study in healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of four formulations of LY03009 (F1, F2, F3, F4) after a single intramuscular injection. Approximately 40 healthy subjects are planned to be enrolled in this study and assigned to four cohorts (F1, F2, F3, F4) sequentially, 10 subjects per group at a fixed dose of 112 mg for F1~F3 and 224 mg for F4. Each subject will receive only one dose in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04593511
Study type Interventional
Source Luye Pharma Group Ltd.
Contact
Status Enrolling by invitation
Phase Phase 1
Start date February 2, 2021
Completion date October 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02915848 - Long-term Stability of LFP Recorded From the STN and the Effects of DBS
Recruiting NCT03648905 - Clinical Laboratory Evaluation of Chronic Autonomic Failure
Terminated NCT02688465 - Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE). Phase 4
Completed NCT05040048 - Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
Active, not recruiting NCT04006210 - Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations Phase 3
Completed NCT02562768 - A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease Phase 1
Completed NCT00105508 - Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia Phase 3
Completed NCT00105521 - Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia Phase 3
Recruiting NCT06002581 - Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease N/A
Completed NCT02236260 - Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation N/A
Completed NCT00529724 - Body Weight Gain, Parkinson, Subthalamic Stimulation Phase 2
Recruiting NCT05699460 - Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
Completed NCT03703570 - A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations Phase 2
Completed NCT03462680 - GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures N/A
Completed NCT02837172 - Diagnosis of PD and PD Progression Using DWI
Not yet recruiting NCT04046276 - Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease N/A
Recruiting NCT02952391 - Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol N/A
Active, not recruiting NCT02937324 - The CloudUPDRS Smartphone Software in Parkinson's Study. N/A
Terminated NCT02894567 - Evaluation of Directional Recording and Stimulation Using spiderSTN N/A
Completed NCT02874274 - Vaccination Uptake (VAX) in PD N/A