to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson's Disease
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04593511
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Angela Molga CMAX Clinical Research Pty Ltd
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