to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers
- Conditions
- Parkinson's Disease
- Interventions
- Drug: LY03009 F4Drug: LY03009 F2Drug: LY03009 F1Drug: LY03009 F3
- Registration Number
- NCT04593511
- Lead Sponsor
- Luye Pharma Group Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Formulation 4 LY03009 F4 a single dose of LY03009 F4 Formulation 2 LY03009 F2 a single dose of LY03009 F2 Formulation 1 LY03009 F1 a single dose of LY03009 F1 Formulation 3 LY03009 F3 a single dose of LY03009 F3
- Primary Outcome Measures
Name Time Method Frequency of adverse events From screening up to day 161 Frequency of adverse events. Apply to cohort F4.
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009 From screening up to day 161 Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of LY03009.Apply to cohort F4
Maximum (peak) plasma concentration (Cmax) of LY03009 From screening up to day 161 Maximum (peak) plasma concentration (Cmax) of LY03009. Apply to cohort F4
Apparent clearance (CL/F) of LY03009 From screening up to day 161 Apparent clearance (CL/F) of LY03009. Apply to cohort F4
Time to maximum plasma concentration (Tmax) of LY03009 From screening up to day 161 Time to maximum plasma concentration (Tmax) of LY03009. Apply to cohort F4
Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009 From screening up to day 161 Area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) of LY03009. Apply to cohort F4
Terminal elimination half-life (t1/2) of LY03009 From screening up to day 161 Terminal elimination half-life (t1/2) of LY03009.Apply to cohort F4
Terminal elimination rate constant (λz) of LY03009 From screening up to day 161 Terminal elimination rate constant (λz) of LY03009. Apply to cohort F4
Mean residence time (MRT) of LY03009 From screening up to day 161 Mean residence time (MRT) of LY03009. Apply to cohort F4
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009 From screening up to day 161 Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) of LY03009. Apply to cohort F4
Apparent volume of distribution (Vz/F) of LY03009 From screening up to day 161 Apparent volume of distribution (Vz/F) of LY03009. Apply to cohort F4
Trial Locations
- Locations (1)
CMAX clinical Research Pty Ltd
🇦🇺Adelaide, South Australia, Australia