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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
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