NCT04593511

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	LY03009 F1	a single dose of LY03009 F1
DRUG	LY03009 F2	a single dose of LY03009 F2
DRUG	LY03009 F3	a single dose of LY03009 F3
DRUG	LY03009 F4	a single dose of LY03009 F4

Timeline

• Start date: 2021-02-02
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2020-10-20
• Last updated: 2021-06-08

Locations

1 site across 1 country: Australia